John W M Yuen1, William W N Tsang2, Sonny H M Tse3, Wings T Y Loo2, Suk-Tak Chan4, Diana L Y Wong3, Hilary H Y Chung3, Jacky K K Tam3, Thomas K S Choi5, Vico C L Chiang3. 1. School of Nursing, the Hong Kong Polytechnic University, Hong Kong Special Administrative Region. Electronic address: john.yuen@polyu.edu.hk. 2. Department of Rehabilitation Sciences, the Hong Kong Polytechnic University, Hong Kong Special Administrative Region. 3. School of Nursing, the Hong Kong Polytechnic University, Hong Kong Special Administrative Region. 4. Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Charlestown, MA, USA. 5. School of Nursing, the Hong Kong Polytechnic University, Hong Kong Special Administrative Region; PolyU-Henry G. Leung Mobile Integrative Health Centre, Centre for Smart Health, School of Nursing, The Hong Kong Polytechnic University, Hong Kong Special Administrative Region.
Abstract
OBJECTIVE: To address the challenges for trialing with elderly and the lacking of valid sham/placebo control, a randomized crossover pilot study is designed and its feasibility on elderly subjects is evaluated. DESIGN: A pilot randomized crossover study was conducted with hydrocollator-based hot pack therapy as active control. Pain intensity, physical disability, depression, general health status, and salivary biomarkers were assessed as outcome measures. RESULTS: Despite there was no significant difference observed between any outcome measures attained by the two interventions, several important differences were noted during the one-week follow-up period. The magnitudes of pain reduction (21-25% versus 16-18%) and disability improvement (45-52% versus 39-42%) were greater in the Gua sha-treated group than the hot pack group. Both treatments were shown to improve flexion, extension and bending movements of the lower back, whereas areas of improvement varied between the two interventions. Decreasing trends were observed in both tumor necrosis factor-alpha (TNF-α) and heme-oxygenase-1 (HO-1) levels following Gua sha. However, rebounds of the biomarkers were observed one week following hot pack. Furthermore, in response to Gua sha, the decrease of TNF-α was strongly correlated with the improvement of physical disability, whereas the physical disability was correlated with the VAS pain intensity. CONCLUSION: It demonstrated a feasible clinical trial protocol for evaluating the effectiveness of Gua sha and other therapeutic modalities. Gua sha may exhibit a more long-lasting anti-inflammatory effect relative to hot pack for pain relief and improved mobility in elderly patients with chronic low back pain.
RCT Entities:
OBJECTIVE: To address the challenges for trialing with elderly and the lacking of valid sham/placebo control, a randomized crossover pilot study is designed and its feasibility on elderly subjects is evaluated. DESIGN: A pilot randomized crossover study was conducted with hydrocollator-based hot pack therapy as active control. Pain intensity, physical disability, depression, general health status, and salivary biomarkers were assessed as outcome measures. RESULTS: Despite there was no significant difference observed between any outcome measures attained by the two interventions, several important differences were noted during the one-week follow-up period. The magnitudes of pain reduction (21-25% versus 16-18%) and disability improvement (45-52% versus 39-42%) were greater in the Gua sha-treated group than the hot pack group. Both treatments were shown to improve flexion, extension and bending movements of the lower back, whereas areas of improvement varied between the two interventions. Decreasing trends were observed in both tumor necrosis factor-alpha (TNF-α) and heme-oxygenase-1 (HO-1) levels following Gua sha. However, rebounds of the biomarkers were observed one week following hot pack. Furthermore, in response to Gua sha, the decrease of TNF-α was strongly correlated with the improvement of physical disability, whereas the physical disability was correlated with the VAS pain intensity. CONCLUSION: It demonstrated a feasible clinical trial protocol for evaluating the effectiveness of Gua sha and other therapeutic modalities. Gua sha may exhibit a more long-lasting anti-inflammatory effect relative to hot pack for pain relief and improved mobility in elderly patients with chronic low back pain.