NCT05258162

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

February 20, 2022

Last Update Submit

February 20, 2022

Conditions

Keywords

Post Traumatic Elbow StiffnessPainElbowDisabilityFracture

Outcome Measures

Primary Outcomes (5)

  • 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

  • ROM Elbow (Flexion)

    Changes from baseline range of motion( ROM) of elbow joint flexion is taken by using Goniometer.

    3rd week

  • ROM Elbow (Extension)

    Changes from baseline range of motion( ROM) of elbow joint extension is taken by using Goniometer.

    3rd week

  • ROM Forearm (Supination)

    Changes from baseline range of motion( ROM) of forearm supination is taken by using Goniometer.

    3rd week

  • ROM Forearm (Pronation)

    Changes from baseline range of motion (ROM) of forearm pronation is taken by using Goniometer.

    3rd week

Secondary Outcomes (2)

  • Disability

    3rd week

  • kinesiophobia (fear of movement)

    3rd week

Study Arms (2)

Mobilization

EXPERIMENTAL

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.

Other: Mobilization

Muscle Energy Technique

EXPERIMENTAL

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.

Other: Muscle Energy Technique

Interventions

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.

Also known as: Hot pack, Range of Motion Exercises, Isometrics
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 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.

Also known as: Hot pack, Range of Motion Exercises, Isometrics
Muscle Energy Technique

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Any ligament injury
  • Patients with Diabetes
  • Patients with RA
  • Patients with Pathological fractures
  • Revision surgeries
  • Neuro-vascular disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benazir Bhutto Hospital

Rawalpindi, Punjab Province, 46300, Pakistan

Location

MeSH Terms

Conditions

Elbow FracturesPainFractures, Bone

Interventions

Range of Motion, ArticularExercise

Condition Hierarchy (Ancestors)

Elbow InjuriesArm InjuriesWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMotor ActivityMovement

Study Officials

  • Muhammad Affan Iqbal, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2022

First Posted

February 28, 2022

Study Start

January 18, 2021

Primary Completion

January 30, 2022

Study Completion

January 30, 2022

Last Updated

February 28, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations