This feasibility study, with limited hypothesis testing, will collect preliminary data for a R01 that will evaluate the efficacy of static magnetic field (SMF) therapy for carpal tunnel syndrome (CTS). Therapeutic magnets are a self-help modality with estimated sales of $350 million in the US in 1999. The objective of this proposal is in alignment with the NCCAM Strategic Plan 2005-2009 encouraging research that will provide consumers with information needed to make decisions about their health care. The scientific literature currently available on SMF therapy in the English language literature is an insufficient base with which to educate consumers. These randomized controlled trials (RCT) reported are marked by heterogeneity of magnetic devices, dosing regimens, duration and frequency of treatments, sham controls and outcomes. CTS is chosen for study because it is a common (prevalence 0.1-3%) and costly condition in terms of medical care and lost days of work. CTS is ideally suited for the rigorous assessment of a novel intervention such as SMF therapy because the diagnosis can be clinically and electrophysiologically confirmed, the target tissues are easily accessible to a quantifiable SMF and validated subjective and objective outcome measures for CTS already exist. Sixty participants with mild to moderate CTS will be recruited and randomized to one of three different magnetic field dosages. For six weeks, during the hours of sleep, participants will wear one of the three magnets taped over the site of the carpal tunnel. Participants will be followed for a post-treatment period of 12 weeks. The Boston Carpal Tunnel Questionnaire (BCTQ) is our primary outcome measure. Five parameters of median nerve conduction studies (NCS) will secondarily be explored for evidence of electrophysiological change in the median nerve.
Specific Aim 1 will assess accrual, retention and compliance rates and adequacy of a blinding protocol.
Specific aim 2 will obtain preliminary data on the safety and effectiveness of three different dosages of SMFs. Effectiveness will be determined using a one-way ANOVA of BCTQ scores comparing all groups at baseline, after a 6-week treatment and at 12 weeks.
Specific Aim 3 will explore electrophysiological changes in median nerve conduction, by comparing NCS at baseline, 6 weeks and after 12 weeks follow-up. This study will provide the data and methodologies needed for conducting a larger RCT of SMF therapy for the treatment of CTS.
| Colbert, Agatha P; Markov, Marko S; Carlson, Nels et al. (2010) Static magnetic field therapy for carpal tunnel syndrome: a feasibility study. Arch Phys Med Rehabil 91:1098-104 |
| Carlson, Hans; Colbert, Agatha; Frydl, Jennifer et al. (2010) Current options for nonsurgical management of carpal tunnel syndrome. Int J Clin Rheumtol 5:129-142 |
| Colbert, Agatha P; Cleaver, James; Brown, Kimberly Ann et al. (2008) Magnets applied to acupuncture points as therapy - a literature review. Acupunct Med 26:160-70 |
