An Exploratory Analysis of Gender as a Potential Modifier of Treatment Effect Among Patients in a Randomized Controlled Trial of Integrative Acupuncture and Spinal Manipulation for Low Back Pain

Kizhakkeveettil, Anupama; Rose, Kevin A.; Kadar, Gena E.; Hurwitz, Eric L.

doi:10.1016/j.jmpt.2018.11.005

Cited by 6 publications

(8 citation statements)

References 29 publications

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“…A randomization list will be generated using a computer random number generator by an independent research assistant (allocation concealed in sealed and opaque envelopes) to attribute an intervention program to each participant. Stratification will be done by sex (because men and women may respond differently to interventions in LBP [ 16 ]) and ODI score: 1) between 10 and 19 and 2) 20 and more to ensure similar level of disability for each group.…”

Section: Methods and Analysismentioning

confidence: 99%

Effect of thermal therapy and exercises on acute low back pain: a protocol for a randomized controlled trial

Côté-Picard

Tittley

Mailloux

et al. 2020

BMC Musculoskelet Disord

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Background Low back pain (LBP) is the first cause of years lived with disability worldwide. This is due to the development of chronic pain. Thus, it is necessary to identify the best therapeutic approaches in the acute phase of LBP to limit the transition to chronic pain. Superficial heat presents the highest level of evidence for short-term reduction in pain and disability in acute LBP. Physical activity is also recommended to avoid transition to chronic LBP, but there is a lack of evidence to determine its effect to reduce acute LBP. Also, the long-term effects of these interventions are unknown. This is a protocol for a randomized controlled trial (RCT) to determine the short and long-term effects of wearable continuous low-level thermal therapy, in combination with exercises or not, on disability and pain. Methods/design Sixty-nine participants with acute LBP will be randomly assigned to one of three intervention programs: 1) thermal therapy, 2) thermal therapy + exercises, and 3) control. The interventions will be applied for 7 continuous days. The primary outcome will be disability and secondary outcomes will be pain intensity, pain-related fear, self-efficacy, number of steps walked and perception of change. The evaluators will be blinded to the interventions, and participants will be blinded to other groups’ interventions. Primary and secondary outcomes will be compared between intervention groups. Discussion This study will provide new evidence about acute LBP treatments, to limit transition to chronicity. This will be the first study to measure the long-term effects of wearable continuous low-level thermal therapy, combined or not to exercises. Trial registration This RCT has been retrospectively registered on ClinicalTrials.gov (NCT03986047) on June 14th, 2019.

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Section: Methods and Analysismentioning

confidence: 99%

Effect of thermal therapy and exercises on acute low back pain: a protocol for a randomized controlled trial

Côté-Picard

Tittley

Mailloux

et al. 2020

BMC Musculoskelet Disord

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“…The outcomes demonstrated gender-specific differences in response to the treatment. Women showed more possibility to reduce pain and disability rates with acupuncture treatment alone, while in men, SMT alone gave better outcomes than acupuncture [20].…”

Section: Gender Differences In Manual Acupuncturementioning

confidence: 96%

“…Differences in response to manual acupuncture based on gender have been reported in both Western and Eastern countries. Recently acupuncture and spinal manipulation therapy (SMT) have been used for treating low-back pain (LBP) in a randomized controlled trial conducted in California by Kizhakkeveettil et al [20]. The outcomes demonstrated gender-specific differences in response to the treatment.…”

Section: Gender Differences In Manual Acupuncturementioning

confidence: 99%

Gender Differences in Manual, Electro, and Laser Acupuncture

Yang¹,

Litscher²

2020

obm icm

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Acupuncture, being a unique method, is a millennia-old tradition in the field of Chinese medicine. However, it is surprising that there are very few scientific publications on acupuncture and its gender-specific effects. This article summarizes the previous work from the perspective of both Western and Eastern medicine, involving manual acupuncture, electro-acupuncture, and modern innovative laser acupuncture. There is scientific evidence that future gender-specific considerations should be included in the assessment of acupuncture therapy success. Thus this topic is interesting and provides leads for future research to the international research community.

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“…In the remaining 238 records, 229 studies were excluded for the following reasons: animal researches, no data available, no back pain, no comparison, inappropriate comparison, reviews. As a result, a total of 9 RCTs were included with 714 patients in this meta-analysis [18][19][20][26][27][28][29][30][31]. The detailed process of studies identi cation and screening was provided in Fig.…”

Section: Literature Searchmentioning

confidence: 99%

“…In some countries, SMT and acupuncture are recommended in international clinical guidelines and as rst-line treatments [10,17]. Some studies comparing the effect of SMT and acupuncture on pain relief and functional improvement showed that SMT was more effective while others had opposite results [18][19][20]. As we know, choosing an effective and safe treatment could avoid wasting time and effort.…”

Section: Introductionmentioning

confidence: 99%

Spinal manipulative therapy and acupuncture for chronic low back pain: a systematic review and meta-analysis of RCTs

Yue

Li²,

Yang

et al. 2021

Preprint

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Background Spinal manipulation therapy (SMT) and acupuncture are commonly used for low back pain (LBP) among complementary and alternative therapies. However, it remains unclear which of the two therapies is more effective for LBP. Therefore, the purpose of this meta-analysis was to evaluate the effectiveness of SMT and acupuncture on LBP. Methods Four electronic databases were searched for randomized controlled trials (all years until July 2021), including PubMed, Embase, Web of Science, and Cochrane Library. Two reviewers independently abstracted data, assessed risk of bias, and rated the quality of evidence. The primary outcome was pain; secondary outcomes included functional status and adverse events. Review Manager 5.3 software and Stata 12.0 were used for all statistical analyses. Results 9 RCTs with a total of 714 participants were identified, who were on average middle aged (39-60 years) without signs of radiating pain. These trials included patients with mild to moderate pain. Overall, moderate quality of evidence suggested that SMT had better effects for pain relief (MD: 0.32, 95%CI: 0.09 to 0.55, I2=34%) and similar effects in function (MD: 0.24, 95%CI: -0.45 to 0.94, I2=21%) when compared to acupuncture. Moderate quality of evidence showed SMT reduced pain better than acupuncture at month 2 (MD: 0.61, 95%CI: 0.08 to 1.14, I2=0%) and at month 12 (MD: 1.02, 95%CI: 0.28 to 1.75, I2=42%). In addition, Low quality of evidence showed SMT may provide better improvement in pain at month 3 (MD: 0.74, 95%CI: 0.09 to 1.39, I2=42%) and in function at month 4 (MD: 3.50, 95%CI: 0.71 to 6.29). Adverse events associated with SMT and acupuncture were rare and mild. Conclusions SMT showed better effects than acupuncture for chronic low back pain, while SMT and acupuncture had similar effects in functional improvement. Although SMT and acupuncture were tolerable and safe, patients should be informed about the potential risks of adverse events before starting therapy.

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An Exploratory Analysis of Gender as a Potential Modifier of Treatment Effect Among Patients in a Randomized Controlled Trial of Integrative Acupuncture and Spinal Manipulation for Low Back Pain

Cited by 6 publications

References 29 publications

Effect of thermal therapy and exercises on acute low back pain: a protocol for a randomized controlled trial

Effect of thermal therapy and exercises on acute low back pain: a protocol for a randomized controlled trial

Gender Differences in Manual, Electro, and Laser Acupuncture

Spinal manipulative therapy and acupuncture for chronic low back pain: a systematic review and meta-analysis of RCTs

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