Elbow FractureMETNCT05258162
Comparison of Mobilization and MET Post-Traumatic Elbow Stiffness
A study testing Mobilization and Muscle Energy Technique in people with Elbow Fracture, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Elbow Fracture
- What is being tested?
- Mobilization and Muscle Energy Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Jan 2021to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Any ligament injury
- Patients with Diabetes
- Patients with RA
- Patients with Pathological fractures
- Revision surgeries
- Neuro-vascular disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Mobilization and Muscle Energy Technique in Patients With Post-Traumatic Elbow Stiffness
The purpose of this study is to find the effects of Mobilization and Muscle energy technique in patients with post-traumatic elbow stiffness.
Read the detailed 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.
- Conditions
- Elbow Fracture
- Being tested
- Mobilization, Muscle Energy Technique
- Keywords
- Post Traumatic Elbow Stiffness, Pain, Elbow, Disability, Fracture
- Medical subject headings
- Elbow Fractures, Pain, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MobilizationOther
Also called Hot pack, Range of Motion Exercises, Isometrics
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 TechniqueOther
Also called Hot pack, Range of Motion Exercises, Isometrics
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Muscle Energy Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 3rd week
ROM Elbow (Flexion)
Changes from baseline range of motion( ROM) of elbow joint flexion is taken by using Goniometer.
Measured: 3rd week
ROM Elbow (Extension)
Changes from baseline range of motion( ROM) of elbow joint extension is taken by using Goniometer.
Measured: 3rd week
ROM Forearm (Supination)
Changes from baseline range of motion( ROM) of forearm supination is taken by using Goniometer.
Measured: 3rd week
ROM Forearm (Pronation)
Changes from baseline range of motion (ROM) of forearm pronation is taken by using Goniometer.
Measured: 3rd week
Secondary outcomes (2)
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)
Measured: 3rd week
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.
Measured: 3rd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start18 Jan 2021
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow FractureStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Affan Iqbal, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258162
- Sponsor's protocol ID
- Riphah/RCRS/REC/00939
- Acronym
- MET
- Status last verified
- Feb 2022
- First submitted
- 20 Feb 2022
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mobilization and Muscle Energy Technique in Patients With Post-Traumatic Elbow Stiffness
- ClinicalTrials.gov ID
- NCT05258162
- Acronym / sponsor ID
- MET / Riphah/RCRS/REC/00939
- Conditions
- Elbow Fracture
- Keywords
- Post Traumatic Elbow Stiffness, Pain, Elbow, Disability, Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find the effects of Mobilization and Muscle energy technique in patients with post-traumatic elbow stiffness.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobilization | Experimental | Other: MobilizationMobilizations 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. |
| Muscle Energy Technique | Experimental | Other: Muscle Energy TechniqueMuscle 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Any ligament injury
- Patients with Diabetes
- Patients with RA
- Patients with Pathological fractures
- Revision surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MobilizationAlso: Hot pack, Range of Motion Exercises, IsometricsHot 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. | Other | Mobilization |
| Muscle Energy TechniqueAlso: Hot pack, Range of Motion Exercises, IsometricsHot 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. | Other | Muscle Energy Technique |
Primary outcome
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'.
ROM Elbow (Flexion)
Time frame: 3rd week
Changes from baseline range of motion( ROM) of elbow joint flexion is taken by using Goniometer.
ROM Elbow (Extension)
Time frame: 3rd week
Changes from baseline range of motion( ROM) of elbow joint extension is taken by using Goniometer.
ROM Forearm (Supination)
Time frame: 3rd week
Changes from baseline range of motion( ROM) of forearm supination is taken by using Goniometer.
ROM Forearm (Pronation)
Time frame: 3rd week
Changes from baseline range of motion (ROM) of forearm pronation is taken by using Goniometer.
2 secondary outcomes
Disability
Time frame: 3rd week
kinesiophobia (fear of movement)
Time frame: 3rd week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Affan Iqbal, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobilization and Muscle Energy Technique in people with Elbow Fracture, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (time frame: 3rd week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.