Thermal Therapy in Patients Suffering from Non-Specific Chronic Low Back Pain—A Systematic Review

Thermal therapy is frequently used as an adjunct to treatment in patients suffering from chronic low back pain. It is also an inherent part of patients’ self-administered pain treatment. This review aims to update the evidence for thermal therapy treatments in non-specific chronic low back pain patients and to rate the methodological quality of the corresponding clinical trials. Previous studies have reported contradictory evidence for the effectiveness of thermal therapy. An electronic search on MEDLINE (PubMed), PEDro, CENTRAL and CINHAL databases was conducted between May 2016 and February 2018. Clinical trials comparing local thermal therapy to conservative or no treatment were assessed for eligibility. Pain, physical function and global health were defined as outcome parameters. A total of n = 9 studies met the inclusion criteria. All of them applied an electrophysical agent as the thermal treatment: continuous ultrasound (n = 6), short-wave diathermy (n = 2), microwave diathermy (n = 1). Out of the n = 6 studies on ultrasound treatment, n = 2 reported significant within and between-group results for pain reduction after 4 to 6 weeks of treatment. Both short-wave diathermy studies demonstrated significant between-group results for pain reduction after 3 weeks of treatment. Contradictory results for all other observed outcome parameters were reported regardless of the intervention. Moreover, significant within-group results for the control groups questioned the effectiveness of the intervention treatments. Therefore, the effect of thermal therapy, (electrophysical agents), is not superior to any control treatment except for ultrasound treatment on short-term pain reduction.

• Electrophysical Agents
• Heat Application
• Pain Reduction
• Physical Function
• Non-Specific Chronic Low Back Pain
• Thermal Therapy

1. Introduction

According to the World Health Organization, chronic pain is a worldwide public health problem [1] . It is defined as “pain lasting longer than normal tissue healing time”, generally taken to be 12 weeks [2] . In looking at the prevalence of chronic low back pain in US citizens over a period of 14 years, there was a significant increase of about 6.3% with no changes in symptom severity or general health [3] . Chronic pain impairs quality of life, work performance and increases healthcare costs [4] . The socio-economic burden of low back pain has been evaluated by several studies [5] [6] [7] . Approximately 80% of low back pain cases are non-specific, meaning that no definite anatomical structure can be associated with neither the medical history nor the clinical examination [8] . Despite existing recommendations for avoiding chronicity of low back pain [9] , non-specific chronic low back pain (NSCLBP) continues to be increasing in prevalence in both developed and developing countries [10] . Several countries provide corresponding treatment and behaviour guidelines [11] highlighting the benefits of physical activity [12] . Strong evidence exists to encourage chronic low back pain patients to follow an active lifestyle and to assume self-responsibility for their health [13] . Despite conflicting evidence [14] [15] [16] [17] , thermal therapy is applied in practice and by patients themselves as a self-management strategy [18] . Thermal therapy comprises the implementation of any superficial heat or warmth application to the skin via conduction or convection [19] . Thermal therapy is believed to influence pain [20] , to increase superficial and deep muscle tissue temperature and blood flow [21] affecting muscle nerve conduction velocity [22] . Electrophysical agents generate heat within the tissue by means of energy conversion (e.g. ultrasound, diathermy) [19] . Allen (2009) stated that “physical agents may serve as useful adjunctive modalities of pain relief or to enhance the effectiveness of other elements in therapy geared toward resolution of movement impairments and restoration of physical function” [15] . Despite these findings, the European guidelines for the management of NSCLBP (2006) do not consider thermal therapy to be more effective than placebo or other treatments neither to relieve pain, nor to improve functional outcome parameters [17] .

Thus, the authors of this review wanted to update the evidence for thermal therapy applications in patients with NSCLBP with respect to pain reduction and improvement of functional outcome parameters and global health and to rate the methodological quality of the included studies.

2. Methods

2.1. Research Question

The research question was defined by the PICOS-model [23] in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement [24] : Population: patients diagnosed with NSCLBP (>3 months symtomatic) aged 18 years or older; Intervention: thermal therapy applications except balneo/spa therapy; Comparator: any kind of treatment except thermal therapy; Outcomes: pain ratings, physical function, global health; Study design: RCT, CCT, CT.

2.2. Literature Search Strategies and Data Sources

An electronic systematic search, according to the guidelines of the PRISMA statement [24] , was conducted between May 2016 and February 2018 on the MEDLINE (PubMed), PEDro (Physiotherapy Evidence Database), CENTRAL (Cochrane Central Register of Controlled Trials), and CINHAL (Cumulative Index to Nursing and Allied Health Literature) databases. The additional filters “randomized controlled trials, clinical trials, controlled clinical trials, English language, full text” were applied in PubMed, the filter “clinical trials” in PEDro, “trials” in CENTRAL and “full text, academic journal” in CINHAL. Grey literature was searched on the websites of Google Scholar, Aspetar Sports Medicine Journal and by screening the Book of Abstracts of the European College of Sports Science (2014-2017). The function “similar articles” on PubMed and screening the reference lists were applied to attain additional literature. MeSH-proven (Medical Subject Headings) keywords were applied where possible (eAddenda Appendix I). The keywords which best fitted the research question among others were: “low back pain”, “heat application”, “hot packs”, “thermal therapy”, “warmth application”. The keywords representing the thermal therapy application were always combined with “AND” and “low back pain” (Table 1). The a priori set inclusion criteria were: 1) RCT, CCT, CT, 2) English full-text availability, 3) participants of 18 years or older diagnosed with NSCLBP, 4) control intervention of any treatment including placebo/sham without using thermal therapy, 5) outcome parameters comprising pain ratings and/or physical function and/or global health. The rationale for inclusion of these outcome variables was comparability. After screening and processing all the articles found (n = 164), a total of n = 9 articles was included in the final data analysis. Figure 1 shows the flow-chart of the selection process.

2.3. Data Extraction and Quality Assessment

The methodological quality of the studies was assessed using the 11-item PEDro scale [25] [26] and the Cochrane Risk of Bias Tool (ROB) [27] . Two researchers (SW, RS) rated independently from each other the n = 9 studies. In case of disagreement or doubt consensus was reached by a third investigator (EH). For trials which PEDro scores were originally listed on the PEDro website

Table 1

Summary of keywords and its combinations of each database

1) Keyword	Boolean function	2) Keyword	Hits per Database
low back pain	AND	diathermy	PubMed: n = 10	PEDro: n = 12	CENTRAL: n = 23	CINHAL: n = 14
		fango packs	PubMed: n = 0	PEDro: n = 0	CENTRAL: n = 0	CINHAL: n = 0
		heat application	PubMed: n = 0	PEDro: n = 1	CENTRAL: n = 1	CINHAL: n = 32
		heat plaster	PubMed: n = 1	PEDro: n = 0	CENTRAL: n = 0	CINHAL: n = 1
		heat wrap	PubMed: n = 4	PEDro: n = 5	CENTRAL: n = 8	CINHAL: n = 16
		hot packs	PubMed: n = 4	PEDro: n = 5	CENTRAL: n = 21	CINHAL: n = 16
		hyperemic cream	PubMed: n = 0	PEDro: n = 0	CENTRAL: n = 0	CINHAL: n = 0
		hyperemic gel	PubMed: n = 0	PEDro: n = 0	CENTRAL: n = 0	CINHAL: n = 0
		hyperemic ointment	PubMed: n = 0	PEDro: n = 0	CENTRAL: n = 0	CINHAL: n = 0
		hyperemic products	PubMed: n = 0	PEDro: n = 0	CENTRAL: n = 0	CINHAL: n = 0
		hyperemia induced	PubMed: n = 13	PEDro: n = 0	CENTRAL: n = 12	CINHAL: n = 9
		mud packs	PubMed: n = 1	PEDro: n = 0	CENTRAL: n = 1	CINHAL: n = 1
		thermal therapy	PubMed: n = 5	PEDro: n = 8	CENTRAL: n = 6	CINHAL: n = 15
		thermotherapy	PubMed: n = 4	PEDro: n = 3	CENTRAL: n = 13	CINHAL: n = 4
		topical hyperemic products	PubMed: n = 0	PEDro: n = 0	CENTRAL: n = 0	CINHAL: n = 0
		topical warming product	PubMed: n = 0	PEDro: n = 0	CENTRAL: n = 0	CINHAL: n = 0
		ultrasonic therapy	PubMed: n = 9	PEDro: n = 30	CENTRAL: n = 27	CINHAL: n = 24
		warming products	PubMed: n = 0	PEDro: n = 0	CENTRAL: n = 0	CINHAL: n = 0
		warming application	PubMed: n = 0	PEDro: n = 0	CENTRAL: n = 0	CINHAL: n = 0

(https://www.pedro.org.au/) [26] , the presented PEDro score was used. The data extraction was performed in the same manner. Data on study design, participants, intervention method, assessment and each outcome parameter were split into corresponding columns on spreadsheets to extract relevant data. The accepted level of significance was set at alpha < 0.05. The between-group difference results were extracted following the completion of the whole treatment in order to observe the overall effect of the specified thermal therapy versus the control intervention.

3. Results

3.1. Total PEDro Score and Risk of Bias Analysis

The total PEDro scores (eAddenda Appendix II) of the included studies were in line with the Risk of Bias results. Figure 2 depicts the Risk of Bias results of each included study and Figure 3 demonstrates the overview of all included studies for this analysis. A low risk of reporting bias was observed in 100% of the analysed studies. A high risk of bias with > 50% contributed to performance and detection bias (Personnel and Outcome assessor) as well as attrition bias. A low risk of bias with > 75% was attained for selection and other bias.

3.2. Study Characteristics

All included studies exclusively applied electrophysical agents as intervention treatment; n = 6 studies used ultrasound treatment [28] - [33] , n = 2 studies applied short-wave diathermy [34] [35] and n = 1 study microwave diathermy [36] (see Figure 4 for detailed overview on the results). All studies, except Licciardone et al. (2013) [32] (USA), were performed in Eastern countries (n = 3 Iran [28] [31] [33] , n = 3 Turkey [29] [30] [36] , n = 2 Bangladesh [34] [35] . The gender

distribution was not mentioned by n = 3 studies [29] [30] [31] , n = 2 studies were conducted with female participants only [30] [36] , and n = 4 studies included male and female participants [28] [32] [34] [35] . Age, BMI (except one) [32] and symptomatic back pain time before enrolment could be extracted from all studies. Treatment sessions ranged from 2 to 18 sessions over 4 to 8 weeks. Four of the included studies did a follow-up measurement, out of them n = 3 one month after the end of treatment [31] [32] [36] and n = 1 after six months post treatment [33] .

The studies comprised a wide range of assessment tools to rate the outcome parameters: pain was assessed by the visual analog scale (VAS) [30] [31] [32] [33] [34] [36] , Lattinnen’s test score [34] [35] and tenderness score [34] . Functional parameters were assessed by trunk mobility (Range of Motion (ROM) [28] [30] [36] , (modified) lumbar Schober test [29] [30] [36] , fingertip to floor distance [29] [30] [36] , trunk muscle strength [30] , endurance [30] [31] [36] , activation [28] [33] , 6-min Walk Test (6MWT)) [30] [36] , and questionnaires (Functional Rating Index (FRI) [28] [31] , Pain Disability Index (PDI) [29] [30] [36] , Oswestry Disability Questionnaire (ODQ) [29] [30] [33] [36] , Back Depression Index (BDI) [36] , Medical Outcomes Study Short Form-36 Health survey general health scale (SF-36 GH) [32] [36] , Roland-Morris Disability Questionnaire (RMDQ)) [32] .

3.3. Treatment Effects on Outcome Parameters

Out of n = 6 studies on ultrasound treatment [28] - [33] a significant within and between-group pain reduction was reported by n = 2 studies, compared to exercise training alone (p = 0.012) [30] or to manipulation treatment (p = 0.001) [33] . Trunk mobility was mentioned in n = 6 studies [28] [29] [30] [31] [33] [36] of which all reported flexion mobility with n = 1 study including lateral flexion [28] and n = 3 studies evaluating extension mobility [28] [31] [33] . Three studies reported significant within-group ROM improvements in flexion [29] [30] [33] for both the intervention and the control group. None of the n = 6 studies showed significant between-group results. Out of the n = 3 studies on extension ROM, n = 2 showed significant within-group results [28] [33] , none of them found significant between-group results in favour of ultrasound treatment compared to placebo ultrasound treatment [28] or manipulation treatment [33] . Right lateral flexion ROM increased significantly within and between the placebo and ultrasound group (p = 0.04, p = 0.032, respectively), whereas left lateral flexion ROM significantly improved within-group (p = 0.04) [28] . 6MWT results, evaluated by n = 1 study, were significant for within and between-groups (p = 0.001, p = 0.024, respectively) [30] . Questionnaire outcomes were used in n = 6 studies [28] - [33] . The FRI score was significant within the placebo and treatment groups, no data on between-group results were mentioned [28] . The time (p < 0.001) and group (p = 0.004) main effects for the ultrasound treatment compared to the placebo intervention were significant in Ebadi et al. (2012), with a non-significant group*time interaction (p = 0.31) [31] . The PDI, ODQ and BDI showed significant within-group results (p = 0.001) for the combined ultrasound and exercise treatment group and exercise group alone and non-significant between group results [29] [30] . Mohseni-Bandpei et al. (2006) reported significant within-group results for the ultrasound group and manipulative control group and significant between-group results (p = 0.001) in favour of manipulation treatment [33] . The SF-36 subscale items showed significant within-group differences for all items (p = 0.001) [29] [30] with significant between-group results for “physical function” (p = 0.009) [29] , “social function” (p = 0.016) [29] and “physical function” (p = 0.021) [30] , “pain” (p = 0.046) [30] and “energy” (p = 0.009) [30] compared to exercise treatment alone. Licciardone et al. (2013) mentioned non-significantly different total SF-36 scores (p = 0.53) and RMDQ outcomes (p = 0.76) between ultrasound treatment and placebo intervention (eAddenda Appendix III) [29] [32] .

Three studies focused on diathermy treatment, n = 2 studies on short-wave diathermy [34] [35] and n = 1 on microwave diathermy [36] . For short-wave diathermy treatment, significant results in pain reduction were mentioned compared to the placebo group (p = 0.0) [34] [35] . Shakoor et al. (2008) reported significant within-group results at all time intervals for both the intervention and the placebo group [35] . Non-significant between-group results for microwave diathermy combined with exercise versus exercise alone (p = 0.496) were mentioned [36] . Trunk mobility in flexion showed no significant difference between the microwave diathermy and exercise group compared to the exercise group alone (p > 0.05) [36] , as well as for 6MWT performance and all reported questionnaire outcomes (p > 0.05) [36] .

4. Discussion

The aim of this systematic review was to assess the evidence for the use of thermal therapy in NSCLBP patients on pain and physical outcome parameters and to evaluate the methodological quality of the corresponding studies.

4.1. Evidence for Thermal Therapy

Despite the search strategy no studies on heat wraps, hot or mud packs fulfilled the inclusion criteria. To evaluate solely the thermal effect of local interventions, unbiased by water pressure or whole-body thermal applications and its physiological reactions, balneo/spa therapy was deliberately omitted as a keyword. However, several clinical trials showed positive short and long-term effects for balneo therapy in CLBP patients on pain, quality of life and physical function [37] [38] .

The findings of this review, for a fraction of electrophysical agents only (continuous ultrasound, short-wave diathermy and microwave diathermy), was that all observed treatment interventions except microwave diathermy [36] significantly improved pain symptoms, with only two studies documenting the intake of oral pain killers [34] [35] . The ineffectiveness of microwave diathermy on pain relief is supported by a study on non-specific chronic neck pain patients [39] . The significant improvement in pain between the groups was underpinned by the SF-36 subscale items physical function, pain and energy [30] . The SF-36 subscale items “physical function, social function, energy” may be positively affected by thermal therapy applied by means of electrophysical agents, of which ultrasound treatment may be superior to diathermy application. Surprisingly, mental health and general health were unaffected by pain reduction [30] . However, control group results showed significant pain reduction over time, limiting the positive effect of any electrophysical treatment for NSCLBP on pain. Supporting this finding, Koldas et al. (2008) reported significant improvements in global health and disability questionnaire results rather than pain reduction for physical therapy intervention group (hot pack, ultrasound and TENS) compared to home exercise alone [40] .

The included studies demonstrated that trunk mobility in the frontal and sagittal planes was indeed reduced in NSCBLP patients but improved independently of treatment, supporting the guidelines’ recommendations to remain physically active, rather than applying thermal therapy [12] [41] . Additionally, NSCLBP patients attained walking distances comparable to healthy subjects [42] , assuming only a marginal negative effect of NSCLBP on walking distance performance and questioning the efficacy of the 6MWT distance as sensitive outcome parameter for NSCLBP. Earlier literature has reported that all forms of therapy have shown a positive effect on depression and global health [43] . This was supported by the questionnaire score results of this review. Moreover, Kurklinsky et al. (2016) challenged pain reduction in chronic pain patients proposing aiming at functional and quality of life improvements instead [44] .

All ultrasound studies applied continuous mode to ensure a thermal effect. Unfortunately, there was a wide heterogeneity in the reported ultrasound settings, although existing literature on ultrasound modalities and corresponding heat rates in specific depths for muscle and connective tissue exist [45] [46] [47] [48] . The participants’ characteristic between the studies was heterogenic in terms of being symptomatic with NSCLBP for a period ranging from 3 months to 12 years. To presume that the duration of symptoms may negatively affect treatment outcomes cannot be supported since even the control groups showed improvement in the assessed outcome parameters.

4.2. Methodological Quality

The mean methodological quality of the included studies did not attain the total PEDro scores proposed by Moseley et al. (2011) [49] . Higher total PEDro scores would have been achievable through thorough reporting of statistical procedures and resolute blinding of personnel and/or outcome assessors [49] [50] . However, the methodological quality did not affect the studies’ outcomes.

4.3. Limitations and Future Research

Figure 2 and Figure 3 depict that the included studies had a high risk of bias for blinding personnel and outcome assessors and an unclear risk of bias for random sequence generation, allocation concealment and other bias. The risk of a selection bias could be reduced by consistent reporting of random sequence generation and allocation concealment. Depending on the chosen thermal therapy treatment blinding of participants may be impossible due to the warming effect, nevertheless, > 50% low risk of bias was achieved. Surprisingly, as accessible, is the high risk of performance, detection bias and attrition bias, since hardly any follow-up measurements were conducted. Future studies are recommended to specify their study protocols and procedures to further reduce the risk of selection, reporting and other bias. Blinding of outcome assessors should become a matter of course, blinding of participants and personnel highly advised wherever possible to ensure a low risk of performance and detection bias. Further, there is a lack of studies using hot packs or heat wraps as applications method, although commonly utilized by patients at home.

5. Conclusion

In line with previous findings [16] [17] , this review included recently published studies reaffirmed the contradictory evidence for thermal therapy on NSCLBP. Only electrophysical treatment methods fulfilled the inclusion criteria. Little evidence for direct post treatment pain reduction exists for continuous ultrasound treatment of 10 minutes’ duration, three days per week for 6 weeks, and short-wave diathermy treatment of 15 minutes’ duration, three days per week for 2 to 3 weeks. This short-term pain reduction achieved may be utilized as preparation for physical activity and exercising [15] [51] . Remaining physically active and attending exercising are the main statements of international guidelines for chronic low back pain. Nevertheless, with respect to the complexity of neurophysiological mechanisms behind chronic pain syndromes, individual therapy and advice should be sought [52] . Although the effect of thermal therapy has been described in literature [19] , as applied by means of electrophysical agents (continuous ultrasound, short-wave and microwave diathermy), the authors conclude that there is only marginal evidence to support its application in patients with NSCLBP.

Acknowledgements

The authors thank Mrs. Lindsay Melcher-Kunz for providing language help and proof reading of the manuscript, and the “Thim van der Laan foundation” for the financial support.

Conflict of Interest

The authors declare no conflict of interest.

Author Contributions

Conceived and designed the experiments: SW, RS, RC. Data extraction and quality assessment: SW, RS, EH. Risk of bias assessment: SW, RS, EH. Analysis of the data: SW, RS. Wrote the paper: SW, RS. Read and approved final version of manuscript: SW, RS, EH, RC.

Appendix I

Table A1

Overview on the MeSH-Term proven keywords

Keywords	MeSH-Term
diathermy	yes
fango packs	no
heat application/wrap	no
hot packs	no
hyperemic cream/gel/ointment/products	no
hyperthermia induced	yes
low back pain	yes
mud packs	yes
thermal therapy	no
thermotherapy	no
topical hyperemic products	no
topical warming products	no
ultrasonic therapy	yes
warming products	no
warmth application	no

Appendix II

Table A2

PEDro-score of the included studies

Author/Items	Random allocation	Concealed allocation	Groups similar at baseline	Participant blinding	Therapist blinding	Assessor blinding	<15% dropouts	Intention-to-treat analysis	Between-group difference reported	Point estimate and variability reported	Total PEDro-score (0 to 10)
Ahmed et al. (2009)	−	−	+	−	−	−	+	−	+	+	4
Ansari et al. (2006)	+	−	−	+	−	+	−	−	+	+	5
Durmus et al. (2010)	+	−	+	+	−	+	−	−	+	+	6
Durmus et al. (2013)	+	+	+	+	+	−	+	+	+	+	9
Durmus et al. (2014)	+	+	+	−	+	−	+	−	+	+	7
Ebadi et al. (2012)	+	+	+	+	−	−	+	+	+	+	8
Licciardone et al. (2013)	+	+	+	+	−	+	+	+	+	+	9
Mohseni-Bandpei et al. (2006)	+	+	+	−	−	+	+	+	+	+	8
Shakoor et al. (2008)	+	+	+	−	−	−	−	−	+	+	5

Legend. + = criteria fulfilled, − = criteria not fulfilled.

Appendix III

Table A3

Detailed overview on the SF-36 questionnaire results

Authors	SF-36 results
Durmus et al. (2010)	Subscale	US + EP (IG, N = 19)	EP (CG, N = 20)	Significance IG vs CG
	Physical function	M0: 75.0 (35 - 85) M1: 90.0 (65 - 100) IG*time: p = 0.001§	M0: 77.5 (60 - 100) M1: 90.0 (70 - 100) CG*time: p = 0.001§	p = 0.009§
	Mental health	M0: 58.31 ± 11.10 M1: 73.05 ± 12.49 IG*time: p = 0.001§	M0: 59.20 ± 11.05 M1: 71.75 ± 10.96 CG*time: p = 0.001§	p = 0.166
	Pain	M0: 44.0 (44 - 88) M1: 88.0 (66 - 99 IG*time: p = 0.001§	M0: 52.0 (44 - 88) M1: 77.0 (65 - 100) CG*time: p = 0.001§	p = 0.285
	General health	M0: 51.05 ± 15.32 M1: 65.52 ± 16.90 IG*time: p = 0.001§	M0: 52.75 ± 17.53 M1: 64.25 ± 15.99 CG*time: p = 0.001§	p = 0.231
	Social function	M0: 55.0 (44 - 88) M1: 77.0 (55 - 88) IG*time: p = 0.001§	M0: 56.0 (33 - 88) M1: 77.0 (44 - 88) CG*time: p = 0.001§	p = 0.016§
	Physical role limitation	M0: 50.0 (0 - 100) M1: 100.0 (75 - 100) IG*time: p = 0.001§	M0: 62.5 (0 - 100) M1: 100.0 (50 - 100) CG*time: p = 0.001§	p = 0.296
	Emotional role limitation	M0: 66.0 (0 - 100) M1: 100.0 (60 - 100) IG*time: p = 0.001§	M0: 66.0 (0 - 100) M1: 100.0 (33 - 100) CG*time: p = 0.001§	p = 0.576
	Energy	M0: 54.73 ± 13.69 M1: 68.68 ± 15.44 IG*time: p = 0.001§	M0: 54.70 ± 13.26 M1: 67.75 ± 14.09 CG*time: p = 0.001§	p = 0.001§
Durmus et al. (2013)	Subscale	US + EP (IG, N = 20)	EP (CG, N = 20)	Significance IG vs CG
	Physical function	M0: 70.00 ± 13.3 M1: 87.00 ± 11.4 IG*time: p = 0.001§	M0: 73.25 ± 12.6 M1: 89.75 ± 11.1 CG*time: p = 0.001§	p = 0.021§
	Mental health	M0: 58.40 ± 10.8 M1: 73.40 ± 12.2 IG*time: p = 0.001§	M0: 56.60 ± 10.1 M1: 74.10 ± 10.1 CG*time: p = 0.001§	p = 0.063
	Pain	M0: 58.65 ± 16.23 M1: 77.20 ± 11.44 IG*time: p = 0.001§	M0: 65.50 ± 17.69 M1: 77.45 ± 12.48 CG*time: p = 0.001§	p = 0.046§
	General health	M0: 51.75 ± 15.24 M1: 61.00 ± 16.59 IG*time: p = 0.001§	M0: 50.25 ± 14.46 M1: 66.75 ± 14.26 CG*time: p = 0.001§	p = 0.180
	Social function	M0: 54.45 ± 13.57 M1: 84.35 ± 12.01 IG*time: p = 0.001§	M0: 58.85 ± 14.39 M1: 86.10 ± 13.09 CG*time: p = 0.001§	p = 0.246
	Physical role limitation	M0: 56.25 ± 33.3 M1: 96.75 ± 8.1 IG*time: p = 0.001§	M0: 60.65 ± 31.2 M1: 90.75 ± 15.2 CG*time: p = 0.001§	p = 0.285

	Emotional role limitation	M0: 61.30 ± 29.2 M1: 96.05 ± 9.91 IG*time: p = 0.001§	M0: 62.55 ± 26.9 M1: 89.05 ± 18.5 CG*time: p = 0.001§	p = 0.258
	Energy	M0: 55.75 ± 14.0 M1: 69.00 ± 15.09 IG*time: p = 0.001§	M0: 53.50 ± 12.7 M1: 72.50 ± 10.4 CG*time: p = 0.001§	p = 0.009§
Durmus et al. (2014)	Subscale	MWD + EP (IG, N = 19)	EP (CG, N = 20)	Significance IG vs CG
	Physical function	M0: 76.84 ± 11.92 M1-M0: 14.47 ± 9.26 M2-M0: 12.89 ± 9.90	M0: 74.50 ± 12.01 M1-M0: 16.25 ± 8.12 M2-M0: 14.25 ± 8.19	p = 0.396 p = 0.771 p = 0.901
	Social function	M0: 53.94 ± 16.20 M1-M0: 11.10 ± 10.80 M2-M0: 10.05 ± 9.58	M0: 67.70 ± 18.32 M1-M0: 11.85 ± 11.30 M2-M0: 9.00 ± 9.15	p = 0.835 p = 0.771 p = 0.749
	Physical role limitation	M0: 67.78 ± 28.06 M1-M0: 26.25 ± 24.9 M2-M0: 0.56 ± 0.47	M0: 59.40 ± 31.14 M1-M0: 31.10 ± 27.10 M2-M0: 0.43 ± 0.57	p = 0.444 p = 0.396 p = 0.380
	Emotional role limitation	M0: 66.84 ± 25.99 M1-M0: 23.31 ± 21.6 M2-M0: 17.78 ± 18.9	M0: 64.20 ± 25.99 M1-M0: 27.30 ± 23.4 M2-M0: 24.55 ± 21.6	p = 0.771 p = 0.380 p = 0.336
	Mental health	M0: 62.84 ± 13.54 M1-M0: 14.73 ± 10.38 M2-M0: 12.94 ± 9.47	M0: 60.20 ± 12.68 M1-M0: 15.95 ± 10.86 M2-M0: 13.75 ± 8.79	p = 0.588 p = 0.813 p = 0.687
	Energy	M0: 62.36 ± 8.22 M1-M0: 17.63 ± 10.05 M2-M0: 13.94 ± 8.75	M0: 57.00 ± 11.85 M1-M0: 17.50 ± 14.64 M2-M0: 14.75 ± 14.18	p = 0.127 p = 0.708 p = 0.771
	Pain	M0: 61.94 ± 12.81 M1-M0: 25.47 ± 13.50 M2-M0: 21.73 ± 13.53	M0: 57.75 ±13.76 M1-M0: 28.60 ± 12.54 M2-M0: 24.65 ± 12.99	p = 0.336 p = 0.749 p = 0.667
	General health	M0: 53.94 ± 16.20 M1-M0: 16.57 ± 14.62 M2-M0: 13.68 ± 13.10	M0: 52.00 ± 14.72 M1-M0: 15.75 ± 12.06 M2-M0: 13.00 ± 9.65	p = 0.569 p = 0.989 p = 0.901
Licciardone et al. (2013)	Total Score	US(IG, N = 233)	sUS(CG, N = 222)	Significance IG vs CG
	SF-36	M0: 72 (56 - 85) M1: 72 (54 - 87) M2: 72 (54 - 85) M3: 72 (52 - 87)	M0: 67 (52 - 82) M1: 72 (52 - 82) M2: 72 (57 - 85) M3: 74 (54 - 87)	M1: p = 0.73 M2: p = 0.53 M3: p = 0.66

Legend. M0, M1, M2, M3 = measurement time points, see Figure 4 for clarification, IG = intervention group, CG = control group, US = ultrasound, EP = exercise program, sUS = sham ultrasound, MWD = microwave diathermy. ^§= significant at α < 0.05.

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