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Chronic PainNCT02374034

Effect of Egoscue Corrective Exercise Prescription on Acute and Short-term Chronic Knee and Hip Pain

A study testing Corrective exercise in people with Chronic Pain, run by Brigham Young University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary purpose of this experimental study was to determine the acute effect following one treatment and the short-term effect after a two-week program of Egoscue corrective exercises on chronic knee and hip pain. Read more about this study

Who is it for?
Ages 18 to 71 years
Conditions the study is for
Chronic Pain
What is being tested?
Corrective exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Apr 2014to Aug 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 71 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

The primary purpose of this experimental study was to determine the acute effect following one treatment and the short-term effect after a two-week program of Egoscue corrective exercises on chronic knee and hip pain.

Read the 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.

Conditions
Chronic Pain
Being tested
Corrective exercise
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Corrective exerciseOther

    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.

Study groups in NCT02374034
Study groupRoleWhat they receive
TreatmentExperimentalExperimental group (n=20) completed a corrective exercise routine, as per the Egoscue Method, at least five days per week for two weeks.
Receives: Other: Corrective exercise
ControlNo interventionThe control group maintained their current lifestyle for the two-week duration of the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in function and pain

    Pain and function will be assessed with the WOMAC, a self-administered, multidimensional questionnaire

    Measured: two weeks

Secondary outcomes (1)
  1. Changes in daily pain

    The VAS will be daily to assess changes in pain over a two week period

    Measured: two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2015 (estimated)
  2. Study startApr 2014
  3. Primary completionAug 2014
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02374034
Sponsor's protocol ID
X13-0032
Status last verified
Feb 2015
First submitted
12 Feb 2015
Last updated
27 Feb 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 16385518
  • 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.

    PubMed 9808348
  • 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.

    PubMed 1589462
  • 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.

    PubMed 19404180
  • 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.

    PubMed 18759315
  • 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.

    PubMed 2213777

Questions about this trial

What is this clinical trial studying?

A study testing Corrective exercise in people with Chronic Pain, run by Brigham Young University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in function and pain (time frame: two weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02374034, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2015.

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