Multisite Pilot of Chiropractic
for Chronic Pelvic Pain

This section was compiled by Frank M. Painter, D.C.
Send all comments or additions to:   Frankp@chiro.org

Chronic pelvic pain (CPP) affects 15% of women and accounts for 10-15% of hysterectomies and 40% of laparoscopies annually in the U.S.    The estimated annual cost of outpatient care for CPP is $2.8 billion,   excluding surgery and hospitalization,   with lost work days attributed to CPP accounting for an additional $555.3 million.

On September 1, 1998,  the Consortial Center for Chiropractic Research,   funded by the Office of Alternative Medicine through the National Institutes of Health,   awarded Palmer Center for Chiropractic Research a grant for a multisite pilot for a randomized clinical trial of chiropractic care for CPP.   Additional funding for the study is being provided by the National Chiropractic Mutual Insurance Company   (NCMIC).

The project has three sites:     Palmer Center for Chiropractic Research,   National College of Chiropractic,   and Northwestern College of Chiropractic.    The project's investigators are:

     Cheryl Hawk, DC, PhD, Principal Investigator
     (Palmer Center for Chiropractic Research);

     Cynthia R. Long, PhD, Coinvestigator
     (Palmer Center for Chiropractic Research);

     Robert Reiter, MD, Coinvestigator
     (University of Iowa Hospitals and Clinics);

     Charles Davis, PhD, Coinvestigator,
     (University of Iowa Department of Preventive Medicine);

    Jerrilyn Backman, DC
     (National College of Chiropractic);

    and Roni Evans, DC, Coinvestigator
     (Northwestern College of Chiropractic).

The abstract of the proposal is listed below.    We expect to be recruiting patients in the fall,   but can't give a definite date yet.    But the abstract will tell you some details of the feasibility study,   which was published in JMPT:

Hawk C,   Long CR,   Azad A    "Chiropractic care for women with chronic pelvic pain:    A prospective single-group intervention study."
JMPT 1997;   20(2):   1-7

Chronic pelvic pain (CPP) in women,   defined as noncyclic pain in the pelvis persisting at least six months,   causes significant pain,   disability and consumption of health care services.    Its prevalence among women in the U.S. is estimated at 14.7%,   and it accounts annually for 10-15% of hysterectomies and 40% of laparoscopies.    Annual cost of outpatient care for CPP is estimated at $2.8 billion,   excluding surgery and hospitalization;   lost work days cost an additional $555.3 million.

CPP is often unresponsive to traditional medical management and may be appropriate for investigation of complementary therapies like chiropractic.    The proposed study is a pilot for a multisite randomized clinical trial to test the hypothesis that chiropractic manipulation reduces CPP-related pain and disability in women.    A feasibility study for this project with 18 CPP patients demonstrated clinically and statistically significant improvement in the primary outcome measure,   the Pain Disability Index (PDI),   after six weeks of chiropractic care.

Clinically and statistically significant improvement was also observed in the mean scores for the Visual Analog Scale for pain,   the Beck Depression Inventory,   and all subscales of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36, RAND 1.0 version).    The specific aims of the proposed study are to:

1)   assess subject recruitment methods in multiple sites;
2)   enhance the experience with RCTs of chiropractic investigators at three chiropractic colleges;
3)   develop the infrastructure for chiropractic RCTs;
4)   refine sample size estimates for a full-scale RCT; and
5)   increase the knowledge base about treatment options for CPP patients.

Palmer Center for Chiropractic Research (PCCR) will provide centralized trial management and will also serve as a clinical center.    National College of Chiropractic (NCC) and Northwestern College of Chiropractic (NWCC) will be collaborating sites.    The Palmer Office of Data Management (ODM) will act as the data coordinating center.

Potential patients will be screened for pathology and diagnosed with CPP by each site's gynecologists and will enter the study after meeting the other inclusion and exclusion criteria.    For this pilot study,   a sample of 60 patients (20 per site) will be randomized into two groups per site.    The study group will receive six weeks of chiropractic treatment,   specifically Flexion-Distraction and manual Trigger Point Therapy techniques,   both well-established chiropractic procedures.    The control group will receive sham chiropractic manipulation combined with light massage to control for the effects of "hands- on" treatment.    Both patients and personnel administering outcome assessments will be blinded to group status.

Because this is a multisite study,   an intention-to-treat analysis will be used to analyze the primary outcome variable (change in PDI from baseline to week 6) using an analysis-of-variance (ANOVA) model with fixed effects for site,   treatment,   and site x treatment interaction.    First,   point estimates and 95% confidence intervals for raw score changes from baseline to six weeks will be presented for each site.    Then,   if considerable site x treatment interaction is not present or if interaction is present,   but the treatment effects are in the same direction for each site,   the point estimates and overall treatment effects will be reported based on a reduced model containing only the main effects of site and treatment.

Return to New Research Projects

Since 1-01-1999