- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02374034
Effect of Egoscue Corrective Exercise Prescription on Acute and Short-term Chronic Knee and Hip Pain
Study Overview
Detailed Description
Participants for this study were recruited from the university community via email announcements and flyers. Participants were adults with chronic knee and/or hip pain. Chronic pain was defined as pain on most days of the week for at least 12 weeks. Individuals were excluded from the study if they (a) had undergone a knee or hip surgery or had sustained a knee or hip injury in the past 12 months, (b) were currently receiving any form of pain treatment such as physiotherapy, chiropractic, intraarticular injections, or prescription pain medications, (c) exhibited a severe lack of mobility, (d) reported an initial pain level < 3 cm on the Visual Analog Scale (VAS) scale, (e) were pregnant, or (f) were unable to understand English. Individuals were not excluded from participation if they were taking non-prescription drugs such as nonsteroidal anti-inflammatory drugs, although they were required to refrain from taking any pain medication during the 12 hours preceding the first, and subsequent assessments. A power analysis using a power level of 80% and alpha set at 0.05 indicated a sample size of 40 participants (20 in the control group and 20 in the exercise group). A large effect size (0.80) was assumed because this has been reported in the literature26 for differences in Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores following an at-home exercise program. Forty-two eligible participants were originally recruited.
All participants completed a pre-participation questionnaire that included questions about age, gender, injuries, pain medication use, and previous or planned total hip and/or knee arthroplasty. Participants completed two versions of the VAS for knee and/or hip pain: one for pain at rest and one for pain during movement. If participants had pain in multiple joints, they were told to record their overall level of pain. Participants were told to indicate their "usual pain" over the past seven days. Participants needed to have a VAS pain score of at least 3 cm (either at rest or during movement) in order to participate in the study. Participants also completed the WOMAC at the time of the visit. Participants' body mass was measured to the nearest 0.1 kg and height to the nearest 0.5 cm using a digital scale and a stadiometer, respectively.
Egoscue Method protocol was followed and a postural alignment specialist trained in postural evaluation conducted an assessment. To reduce possible inter-rater error, the same researcher conducted all postural evaluations. An individualized exercise program (E-cise menu) was generated using the ePeteTM software (version 4.4.3) based on the noted postural deviations. To ensure that all participants were prescribed the same volume of exercise, the E-cise menus were adjusted by adding or removing exercises so the time required to complete the exercises was approximately 45 minutes.
Participants in the exercise group were led through their complete E-cise menu by the researcher to ensure competency on the exercises. Participants in the control group did not perform any exercises for 45 minutes. Following the first exercise session or 45 minutes of rest, participants completed the VAS again for their current knee and/or hip pain at rest and with movement.
All participants were given logs (one for each day of the week), which they were to fill out every evening before retiring to bed. These logs contained questions about their compliance to the E-cise menu (for those in the exercise group), pain medication use, and a VAS for pain at rest and during movement. Participants in the control group were instructed to maintain their current lifestyle for the two week duration of the study and a return visit was scheduled one week later. Participants in the exercise group were scheduled for a return visit the following day so that E-cises could be observed for competency and any adjustments could be made to the E-cise menu if participants were experiencing pain during an E-cise. Participants in the exercise group were instructed to complete their E-cise menu at home on at least five days of the week, but preferably every day, for the next two weeks.
All participants were assessed and evaluated on all variables previously mentioned at the end of week number 1 and again at the end of the study after week number 2. Participants in the control group were given a personalized E-cise menu, along with instructions, at this time.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- participants with either or both of chronic hip and knee pain
- pain will be defined as pain on most days of the week for at least 12 weeks
Exclusion Criteria:
- undergone a knee or hip surgery or had sustained a knee or hip injury in the past 12 months
- currently receiving any form of pain treatment such as physiotherapy, chiropractic, intraarticular injections, or prescription pain medications
- exhibited a severe lack of mobility
- reported an initial pain level < 3 cm on the Visual Analog Scale (VAS) scale
- pregnant
- unable to understand English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
Experimental group (n=20) completed a corrective exercise routine, as per the Egoscue Method, at least five days per week for two weeks.
|
Participants were assigned to either the exercise group, which performed Egoscue corrective exercises for two weeks, or the control group, which did not receive any treatment for two weeks.
|
No Intervention: Control
The control group maintained their current lifestyle for the two-week duration of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in function and pain
Time Frame: two weeks
|
Pain and function will be assessed with the WOMAC, a self-administered, multidimensional questionnaire
|
two weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in daily pain
Time Frame: two weeks
|
The VAS will be daily to assess changes in pain over a two week period
|
two weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ferraz MB, Quaresma MR, Aquino LR, Atra E, Tugwell P, Goldsmith CH. Reliability of pain scales in the assessment of literate and illiterate patients with rheumatoid arthritis. J Rheumatol. 1990 Aug;17(8):1022-4.
- Hootman JM, Helmick CG. Projections of US prevalence of arthritis and associated activity limitations. Arthritis Rheum. 2006 Jan;54(1):226-9. doi: 10.1002/art.21562.
- Verhaak PFM, Kerssens JJ, Dekker J, Sorbi MJ, Bensing JM. Prevalence of chronic benign pain disorder among adults: a review of the literature. Pain. 1998 Sep;77(3):231-239. doi: 10.1016/S0304-3959(98)00117-1.
- Griegel-Morris P, Larson K, Mueller-Klaus K, Oatis CA. Incidence of common postural abnormalities in the cervical, shoulder, and thoracic regions and their association with pain in two age groups of healthy subjects. Phys Ther. 1992 Jun;72(6):425-31. doi: 10.1093/ptj/72.6.425.
- Kuo YL, Tully EA, Galea MP. Sagittal spinal posture after Pilates-based exercise in healthy older adults. Spine (Phila Pa 1976). 2009 May 1;34(10):1046-51. doi: 10.1097/BRS.0b013e31819c11f8.
- Hernandez-Molina G, Reichenbach S, Zhang B, Lavalley M, Felson DT. Effect of therapeutic exercise for hip osteoarthritis pain: results of a meta-analysis. Arthritis Rheum. 2008 Sep 15;59(9):1221-8. doi: 10.1002/art.24010.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- X13-0032
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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