- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06049238
Comparison of Post Facilitation Stretch and Maitland Mobilization in Post-traumatic Stiff Elbow
March 4, 2024 updated by: Riphah International University
Comparison of Post Facilitation Stretch and Maitland Mobilization in Improving Range of Motion in Post-traumatic Stiff Elbow
This research study aims to bridge the gap in the existing literature by comparing the efficacy of Maitland mobilization and PFS techniques in the treatment of post-traumatic stiff elbow.
While existing research has shown the favorable effects of joint mobilization and muscle energy techniques in other musculoskeletal conditions, there is a notable gap in understanding their efficacy in post-traumatic stiff elbow, particularly in Pakistan where no such study has been conducted.
By investigating the comparative outcomes of these techniques, this research will contribute valuable clinical insights, potentially guiding clinicians in selecting the most effective treatment approach and laying the foundation for evidence-based treatment protocols tailored to patients with post-traumatic stiff elbow.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The elbow being a highly constrained synovial hinge joint has a high propensity for degeneration and stiffness.
There could be functional losses seen with even less severe loss of range of motion (ROM) at the elbow.
The stiff or contracted elbow is defined as an elbow with a reduction in extension greater than 30 degrees, and/or a flexion less than 120 degrees.
Although supination and pronation are often reduced as well, this will not be considered further as contracture of the elbow is not related to forearm rotation.
The elbow is more prone to stiffness because Brachialis muscle lies directly over the anterior capsule, the anterior capsule tends to tear more frequently than posterior, all 3 elbow articulations exist in 1 capsule, the elbow is prone to development of Heterotrophic Ossification.
Loss of terminal extension is less disabling than loss of the same degree of terminal flexion.
It was a randomized, controlled trial, conducted among post-traumatic stiff elbow patients.
Sample size was 32 by using G Power Calculator.
Participants were randomly assigned to the intervention or control group after a baseline assessment with a lottery ticket and an opaque envelope.
All participants in both groups were evaluated on two occasions: (i) baseline (ii) After 4 weeks of intervention
Study Type
Interventional
Enrollment (Actual)
32
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
-
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Punjab
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Rawalpindi, Punjab, Pakistan, 46300
- Railway General Hospital
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-
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
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 18 - 35 years
- Both male and female
- Patients with a limitation of elbow joint range of motion greater than 30 degrees in extension and less than 120 degrees in flexion.
- 2-3 months after POP, splinting
- Patients having bone ossification on X-ray findings will be included.
Exclusion Criteria:
- Patients with a history of rheumatoid arthritis or other inflammatory joint diseases
- Mal-union or non- union elbow fracture.
- Patients with a history of neuromuscular disorders or other conditions affecting muscle tone.
- Patients with a history of previous elbow surgery or joint replacement.
- Patients with a history of traumatic brain injury or other neurological conditions affecting upper limb function.
- Patients with open reduction
- Patient with elbow dislocation
- Elbow joint mal-alignment
- Heterotopic ossification
- Myositis ossification or posttraumatic ankyloses.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Maitland Mobilization
Maitland mobilization will be applied 2-3 oscillations per second for 1 minute, 5 set each day, 5 days a week for 4 weeks.
|
|
|
Active Comparator: post facilitation stretch
PFS will be performed 6-10s isometric contraction with 100 % force followed by 15s passive stretch, 4-5 repetitions per day, 5 days a week for 4 weeks.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric pain rating scale
Time Frame: 4 weeks
|
Changes from baseline Numeric pain rating scale is a self-administered, or analyst reported, measuring instrument comprising of a scale that shows numerical ranges usually from 0-10 or 0-100.
In this scale extreme or farthest point shows having 'no pain' to having 'extreme pain'.
|
4 weeks
|
|
ROM Elbow (Flexion)
Time Frame: 4 weeks
|
Changes from baseline range of motion( ROM) of elbow joint flexion is taken by using Goniometer.
|
4 weeks
|
|
ROM Elbow (Extension)
Time Frame: 4 weeks
|
Changes from baseline range of motion( ROM) of elbow joint extension is taken by using Goniometer.
|
4 weeks
|
|
ROM Forearm (Supination)
Time Frame: 4 weeks
|
Changes from baseline range of motion( ROM) of forearm supination is taken by using Goniometer.
|
4 weeks
|
|
ROM Forearm (Pronation)
Time Frame: 4 weeks
|
Changes from baseline range of motion (ROM) of forearm pronation is taken by using Goniometer.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disability
Time Frame: 4 weeks
|
Changes from baseline disability is measured through DASH (Disability of the arm, shoulder and hand) questionnaire.
DASH questionnaire is a self reported area specific outcome measuring tool for symptoms and disabilities in upper limb.
It mainly comprise of a 30-items scale which is further consist of questions related to difficulty in performing normal daily activities, scored on 5 response options.
Scores for these 30 items then calculate on a scale of 0 (no disability) to 100 (most severe disability)
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nadia ishtiaq, MSOMPT, Riphah International University
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
- 2. Manske RC, Magee DJ. Orthopedic physical assessment-E-Book: Elsevier Health Sciences; 2020. 3. Nandi S, Maschke S, Evans PJ, Lawton JNJH. The stiff elbow. 2009;4(4):368-79. 4. Bruno RJ, Lee ML, Strauch RJ, Rosenwasser MPJJ-JotAAoOS. Posttraumatic elbow stiffness: evaluation and management. 2002;10(2):106-16. 5. Doornberg JN, Ring D, Jupiter JBJJoot. Static progressive splinting for posttraumatic elbow stiffness. 2006;20(6):400-4. 6. Edward SJKM. Elbow passive motion rehabilitation utilizing a continuous passive motion device following surgical release, manipulation under anesthesia, or post stable fracture: A review. 2006. 7. MacDermid JC, Vincent JI, Kieffer L, Kieffer A, Demaiter J, MacIntosh SJTooj. A survey of practice patterns for rehabilitation post elbow fracture. 2012;6:429.
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)
February 15, 2023
Primary Completion (Actual)
January 15, 2024
Study Completion (Actual)
January 15, 2024
Study Registration Dates
First Submitted
September 15, 2023
First Submitted That Met QC Criteria
September 21, 2023
First Posted (Actual)
September 22, 2023
Study Record Updates
Last Update Posted (Estimated)
March 5, 2024
Last Update Submitted That Met QC Criteria
March 4, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- RCRAHS-ISB/REC/MS-PT/01608
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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