Post Traumatic Stiff ElbowNCT06049238
Comparison of Post Facilitation Stretch and Maitland Mobilization in Post-traumatic Stiff Elbow
A study testing Maitland Mobilization and Post facilitation stretch in people with Post Traumatic Stiff Elbow, run by Riphah International University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Post Traumatic Stiff Elbow
- What is being tested?
- Maitland Mobilization and Post facilitation stretch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2023to 15 Jan 2024
- 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
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Patient with elbow dislocation
- Elbow joint mal-alignment
- Heterotopic ossification
- Myositis ossification or posttraumatic ankyloses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Post Traumatic Stiff Elbow
- Being tested
- Maitland Mobilization, Post facilitation stretch
- Keywords
- Post facilitation stretch., Maitland., Stiff elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maitland MobilizationOther
- Hot Pack for 10 mints
- Active and active-assisted exercises (10 reps x 3 sets) for the
- Elbow flexion and extension
- Wrist flexion and extension
- Forearm supination and pronation
Post facilitation stretchOther
- Hot Pack for 10 mints
- Active and active-assisted exercises (10 reps x 3 sets) for the
- Elbow flexion and extension
- Wrist flexion and extension
- Forearm supination and pronation
| Study group | Role | What they receive |
|---|---|---|
| Maitland Mobilization | Experimental | Maitland mobilization will be applied 2-3 oscillations per second for 1 minute, 5 set each day, 5 days a week for 4 weeks. Receives: Other: Maitland Mobilization |
| post facilitation stretch | Active comparator | 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. Receives: Other: Post facilitation stretch |
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: 4 weeks
ROM Elbow (Flexion)
Changes from baseline range of motion( ROM) of elbow joint flexion is taken by using Goniometer.
Measured: 4 weeks
ROM Elbow (Extension)
Changes from baseline range of motion( ROM) of elbow joint extension is taken by using Goniometer.
Measured: 4 weeks
ROM Forearm (Supination)
Changes from baseline range of motion( ROM) of forearm supination is taken by using Goniometer.
Measured: 4 weeks
ROM Forearm (Pronation)
Changes from baseline range of motion (ROM) of forearm pronation is taken by using Goniometer.
Measured: 4 weeks
Secondary outcomes (1)
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: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start15 Feb 2023
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stiff ElbowStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia ishtiaq, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049238
- Sponsor's protocol ID
- RCRAHS-ISB/REC/MS-PT/01608
- Status last verified
- Mar 2024
- First submitted
- 15 Sep 2023
- Last updated
- 5 Mar 2024
- 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 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post Facilitation Stretch and Maitland Mobilization in Improving Range of Motion in Post-traumatic Stiff Elbow
- ClinicalTrials.gov ID
- NCT06049238
- Acronym / sponsor ID
- RCRAHS-ISB/REC/MS-PT/01608
- Conditions
- Post Traumatic Stiff Elbow
- Keywords
- Post facilitation stretch., Maitland., Stiff elbow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 22 Sep 2023 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maitland Mobilization | Experimental | Other: Maitland MobilizationMaitland mobilization will be applied 2-3 oscillations per second for 1 minute, 5 set each day, 5 days a week for 4 weeks. |
| post facilitation stretch | Active comparator | Other: Post facilitation stretchPFS 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| Maitland Mobilization* Hot Pack for 10 mints * Active and active-assisted exercises (10 reps x 3 sets) for the * Elbow flexion and extension * Wrist flexion and extension * Forearm supination and pronation | Other | Maitland Mobilization |
| Post facilitation stretch* Hot Pack for 10 mints * Active and active-assisted exercises (10 reps x 3 sets) for the * Elbow flexion and extension * Wrist flexion and extension * Forearm supination and pronation | Other | post facilitation stretch |
Primary outcome
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'.
ROM Elbow (Flexion)
Time frame: 4 weeks
Changes from baseline range of motion( ROM) of elbow joint flexion is taken by using Goniometer.
ROM Elbow (Extension)
Time frame: 4 weeks
Changes from baseline range of motion( ROM) of elbow joint extension is taken by using Goniometer.
ROM Forearm (Supination)
Time frame: 4 weeks
Changes from baseline range of motion( ROM) of forearm supination is taken by using Goniometer.
ROM Forearm (Pronation)
Time frame: 4 weeks
Changes from baseline range of motion (ROM) of forearm pronation is taken by using Goniometer.
1 secondary outcome
Disability
Time frame: 4 weeks
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 5 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Post Traumatic Stiff Elbow
Not yet recruiting
Comparison of GMI, PNF, and Standard Care for Post-Traumatic Elbow Stiffness Rehabilitation in Adults
Elbow Stiffess, Rehabilitation Treatment
Not yet recruiting
Comparative Effects of Mulligan Mobilization With and Without Myofascial Release Technique in Management of Post Traumatic Elbow Stiffness
Elbow Stiffness, Elbow Pain
Recruiting
Effect of Muscle Energy Technique in Children With Post Traumatic Elbow Stiffness
Elbow Injuries
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.
Nadia ishtiaq, MSOMPT 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 Maitland Mobilization and Post facilitation stretch in people with Post Traumatic Stiff Elbow, 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 5 inclusion and 10 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 5 Mar 2024. 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: 4 weeks). 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 5 Mar 2024.