- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04995250
Effects of Corrective Exercise Training for Improving Neuropathic Pain and Function in Knee Osteoarthritis
August 27, 2021 updated by: Riphah International University
Patients with neuropathic pain had longer duration of symptoms increased severity of pain, functional limitation and disability as compare to the patient with general knee osteoarthritis.
Objective: To find out the effects of corrective exercise training for improving neuropathic pain and function in knee OA patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study was a Quasi experimental study.
It was conducted at Horizon Hospital Johar Town Lahore.
The study was completed in Six months.
Consecutive sampling technique was used to collect the data.
The sample size of 16 patients was taken in this study to find out the effects of corrective exercises training for improving neuropathic pain and function in patients with knee osteoarthritis.
For descriptive analysis we used frequency, percentages and charts.
For quantitative measure.
Repeated Measured ANOVA was used.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Riphah Rehabilitation Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ACR Criteria for osteoarthritis
- Neuropathic pain
- Age over 65
- DN4 cut off value is 4/10
- Less than 30 minutes of morning stiffness
- Grade I and II
- Crepitus on active motion
- Bony tenderness
- Bony enlargement
- No palpable warmth of synovium
Exclusion Criteria:
- Knee complain that require urgent medical attention (fracture and infection)
- Diabetes mellitus
- Patients with malignancies
- Neurological disorders
- Systematic musculoskeletal diseases (Parkinson's, rheumatoid arthritis etc)
- Incapability of understanding implication of participants
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Corrective exercise training for knee Osteoarthritis
|
All patients received 12 weeks (3 days per week) physiotherapy sessions with hot pack, TENS and Ultrasound session for 10 mints and knee isometric, quad strengthening, adductor and abductor strengthening, calf stretch, hamstring stretch, Maitland mobilization, Unconventional Corrective knee exercise protocol treatment: standing on one extremity, up and down on bosu exercise, walking to lateral direction, walking to anterio-posterior direction, walking to anterio-posterior and lateral for 20 mints.
Data were collected at baseline, at week 4 and at post treatment (week 12).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Western Ontario and McMaster Osteoarthritis Index
Time Frame: 6 months
|
0-100, 0 means no disability 100 means maximum disability
|
6 months
|
|
Numeric pain rating scale
Time Frame: 6 months
|
0-10,no pain and the worse pain, on an 11 point scale
|
6 months
|
|
Douleur Neuropathique 4 Questionnaire
Time Frame: 6 months
|
The total score is calculated as the sum of 10 items and the cut off value for the diagnosis of neuropathic pain is a total score of 4/10
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Knoop J, Steultjens MP, van der Leeden M, van der Esch M, Thorstensson CA, Roorda LD, Lems WF, Dekker J. Proprioception in knee osteoarthritis: a narrative review. Osteoarthritis Cartilage. 2011 Apr;19(4):381-8. doi: 10.1016/j.joca.2011.01.003. Epub 2011 Jan 18.
- Polat CS, Dogan A, Sezgin Ozcan D, Koseoglu BF, Kocer Akselim S. Is There a Possible Neuropathic Pain Component in Knee Osteoarthritis? Arch Rheumatol. 2017 Apr 24;32(4):333-338. doi: 10.5606/ArchRheumatol.2017.6006. eCollection 2017 Dec.
- Nelson AE, Allen KD, Golightly YM, Goode AP, Jordan JM. A systematic review of recommendations and guidelines for the management of osteoarthritis: The chronic osteoarthritis management initiative of the U.S. bone and joint initiative. Semin Arthritis Rheum. 2014 Jun;43(6):701-12. doi: 10.1016/j.semarthrit.2013.11.012. Epub 2013 Dec 4.
- Takacs J, Carpenter MG, Garland SJ, Hunt MA. The role of neuromuscular changes in aging and knee osteoarthritis on dynamic postural control. Aging Dis. 2013 Jan 15;4(2):84-99. Print 2013 Apr.
- Beckwee D, Vaes P, Cnudde M, Swinnen E, Bautmans I. Osteoarthritis of the knee: why does exercise work? A qualitative study of the literature. Ageing Res Rev. 2013 Jan;12(1):226-36. doi: 10.1016/j.arr.2012.09.005. Epub 2012 Sep 28.
- Sazo-Rodriguez S, Mendez-Rebolledo G, Guzman-Munoz E, Rubio-Palma P. The effects of progressive neuromuscular training on postural balance and functionality in elderly patients with knee osteoarthritis: a pilot study. J Phys Ther Sci. 2017 Jul;29(7):1229-1235. doi: 10.1589/jpts.29.1229. Epub 2017 Jul 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2020
Primary Completion (ACTUAL)
November 30, 2020
Study Completion (ACTUAL)
December 30, 2020
Study Registration Dates
First Submitted
March 26, 2021
First Submitted That Met QC Criteria
July 29, 2021
First Posted (ACTUAL)
August 6, 2021
Study Record Updates
Last Update Posted (ACTUAL)
September 2, 2021
Last Update Submitted That Met QC Criteria
August 27, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/Lhr/1065
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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