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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05258162
Other study ID # Riphah/RCRS/REC/00939
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 18, 2021
Est. completion date January 30, 2022

Study information

Verified date February 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to find the effects of Mobilization and Muscle energy technique in patients with post-traumatic elbow stiffness.


Description:

A randomized control trial was conducted at Benazir Bhutto Hospital, Rawalpindi. The sample size with reference to parent article was 10 calculated through open epi tool. But 30 patients were included in the study to increase the statistical power of analysis. The participants were divided into two interventional groups i.e. Group A and Group B, each having 15 participants. The study duration was 1 year. Sampling Technique applied was non probability purposive sampling technique. Random Allocation will be through sealed envelope method into two treatment group i.e. Group A and Group B. Only 18-35 years old patients (both male and female) with Post-traumatic elbow stiffness were included in the study. Tools that were used in the study are NPRS, DASH questionnaire, TAMPA scale and Goniometer. Total duration of treatment for both groups was 3 weeks, 3 days a week. Pre and post assessment was done. Data was analyzed through SPSS version 23.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 30, 2022
Est. primary completion date January 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Mobilization
Hot pack for ten minutes. Active and active-assisted exercises for the: Elbow flexion and extension Wrist flexion and extension Forearm supination and pronation Lock and key exercises. Shoulder flexion, extension, abduction, adduction, and rotation (10 repetitions x 1sets) Low-intensity isometric resistance exercises for; Elbow flexion and extension Forearm supination and pronation (10 sec hold) (10 repetitions x 1 set) Resistance will be provided manually by the therapist. Along all these exercises Mobilisations are performed with minimum 6 seconds distraction stretch followed by partial release then followed by slow intermittent stretch at 3-4 seconds intervals. 3 days per week for 3 weeks. Oscillations for 2 minutes at 2-3 oscillations per second.
Muscle Energy Technique
Hot pack for ten minutes. Active and active-assisted exercises for the: Elbow flexion and extension Wrist flexion and extension Forearm supination and pronation Lock and key exercises. Shoulder flexion, extension, abduction, adduction, and rotation (10 repetitions x 1sets) Low-intensity isometric resistance exercises for; Elbow flexion and extension Forearm supination and pronation (10 sec hold) (10 repetitions x 1 set) Resistance will be provided manually by the therapist. Along all these exercises 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. 3 days per week for 3 weeks.

Locations

Country Name City State
Pakistan Benazir Bhutto Hospital Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric pain rating scale 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
Primary ROM Elbow (Flexion) Changes from baseline range of motion( ROM) of elbow joint flexion is taken by using Goniometer. 3rd week
Primary ROM Elbow (Extension) Changes from baseline range of motion( ROM) of elbow joint extension is taken by using Goniometer. 3rd week
Primary ROM Forearm (Supination) Changes from baseline range of motion( ROM) of forearm supination is taken by using Goniometer. 3rd week
Primary ROM Forearm (Pronation) Changes from baseline range of motion (ROM) of forearm pronation is taken by using Goniometer. 3rd week
Secondary Disability 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
Secondary kinesiophobia (fear of movement) 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
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