- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05258162
Comparison of Mobilization and MET Post-Traumatic Elbow Stiffness (MET)
Comparison of Mobilization and Muscle Energy Technique in Patients With Post-Traumatic Elbow Stiffness
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46300
- Benazir Bhutto Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with post-operative elbow stiffness after distal end extra-articular humerus fractures.
- Patients with proximal radius ulna fractures.
- Minimum immobilization period of 3 weeks
Exclusion Criteria:
- Any ligament injury
- Patients with Diabetes
- Patients with RA
- Patients with Pathological fractures
- Revision surgeries
- Neuro-vascular disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Mobilization
Mobilizations are performed with minimum 6 seconds distraction stretch followed by partial release then followed by slow intermittent stretch at 3-4 seconds intervals. Oscillations for 2 minutes at 2-3 oscillations per second. |
Hot pack for ten minutes. Active and active-assisted exercises for the:
Other Names:
|
|
EXPERIMENTAL: Muscle Energy Technique
Muscle Energy Technique is given in the form of post isometric relaxation with 5-7 sec hold for 8-10 repetitions followed by a gentle passive stretch.
Only 20% resistance is offered to the isometric contraction.
|
Hot pack for ten minutes. Active and active-assisted exercises for the:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric pain rating scale
Time Frame: 3rd week
|
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'.
|
3rd week
|
|
ROM Elbow (Flexion)
Time Frame: 3rd week
|
Changes from baseline range of motion( ROM) of elbow joint flexion is taken by using Goniometer.
|
3rd week
|
|
ROM Elbow (Extension)
Time Frame: 3rd week
|
Changes from baseline range of motion( ROM) of elbow joint extension is taken by using Goniometer.
|
3rd week
|
|
ROM Forearm (Supination)
Time Frame: 3rd week
|
Changes from baseline range of motion( ROM) of forearm supination is taken by using Goniometer.
|
3rd week
|
|
ROM Forearm (Pronation)
Time Frame: 3rd week
|
Changes from baseline range of motion (ROM) of forearm pronation is taken by using Goniometer.
|
3rd week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disability
Time Frame: 3rd week
|
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)
|
3rd week
|
|
kinesiophobia (fear of movement)
Time Frame: 3rd week
|
Changes from baseline kinesiophobia is measured through Tampa scale which is a 17 item scale.
Total scores of this scale ranges from 17-68.
Where 17 means no kinesiophobia and 68 means severe kinesiophobia while score of ± 37 indicates that there is kinesiophobia.
|
3rd week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Riphah/RCRS/REC/00939
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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