Rotator Cuff TendinopathyNCT06707857
Effects of TNT on Pain, ROM and Disability in Patients With RC Tendinopathy
A study testing tendon neuroplastic training and conventional training in people with Rotator Cuff Tendinopathy, run by Riphah International University at 1 site in Pakistan.
Trial summary
EFFECTS OF TENDON NEUROPLASTIC TRAINING ON PAIN, RANGE OF MOTION AND DISABILITY IN PATIENTS WITH ROTATOR CUFF TENDINOPATHY Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Tendinopathy
- What is being tested?
- tendon neuroplastic training and conventional training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2024to Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a current shoulder complaint lasting at least three months prior to the time of enrollment
- Pain is located in the proximal lateral aspect of the upper arm (C5 dermatome)
- Positive Hawkins-Kennedy test
Who cannot join
- Bilateral shoulder pain
- Less than 90 degrees of active elevation of the arm
- Corticosteroid injection within the last six weeks
- Radiologically verified fracture
- Glenohumeral osteoarthritis
- Surgery or dislocation of the affected shoulder
Show all 9Show fewer
- Symptomatic arthritis in the Ac joint
- Frozen shoulder
- Symptoms derived from the cervical spine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah Rehabilitation clinic
Lahore, Punjab Province
Ali Raza, MS-OMPT, 0332 6099065
Sheeza kalsoom, MS-OMPT
About this study
Official title: Effects of Tendon Neuroplastic Training on Pain, Range of Motion and Disability in Patients With Rotator Cuff Tendinopathy
EFFECTS OF TENDON NEUROPLASTIC TRAINING ON PAIN, RANGE OF MOTION AND DISABILITY IN PATIENTS WITH ROTATOR CUFF TENDINOPATHY
Read the detailed description
Rotator cuff tendinopathy is a condition where the shoulder's tendon suffers small tears or inflammation, often causing pain frequently arises from repetitive overuse or the natural aging process Regular overhead activities can aggravate the shoulder's wear and tear, leading to tendinosis. The purpose of this study is to evaluate and compare the impact of tendon neuroplastic training with standard treatments on pain levels, functional disability, and the range of motion in patients suffering from rotator cuff tendinopathy. Data were collected from Riphah rehabilitation clinic Lahore. Nprs , goinmeter and Spadi questioner were used before and after the intervention. Assessment was done through the tool before and after the treatment.
- Conditions
- Rotator Cuff Tendinopathy
- Being tested
- tendon neuroplastic training, conventional training
- Keywords
- Rotator cuff tendiopathy, Tendon neuroplastic training, Disability, Range of motion, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tendon neuroplastic trainingOther
Throughout the training, participants pain, range of motion and disability were monitored and they were asked to report any discomfort or unusual sign.
conventional trainingOther
Throughout the training, participants pain, range of motion and disability were monitored and they were asked to report any discomfort or unusual sign.
| Study group | Role | What they receive |
|---|---|---|
| Tendon neuroplastic training | Experimental | Group A will be treated with tendon neuroplastic training. The exercise involved isolated abduction external rotation ,internal rotation and flexion paced to an external audio cue on the patients' smartphone The patient was to listen to the sound and track the movement of the metronome with his eyes, as pacing to these types of external cues has been shown to modulate conspiratorial excitability.The pace of the metronome was set to 6 beats per minute such that each beat was ten seconds apart. This allowed a ten second isometric, eccentric and concentric phase, in 30 seconds totally. Three sets of 10 repetitions of slow progressive exercises (eccentric, concentric and isometric respectively) of the wrist rotator cuff muscles at each treatment session were performed, with 1-min rest interval between each set.
The patient followed the supervised exercise programme 3 times a week for 6 weeks Receives: Other: tendon neuroplastic training |
| Conventional training | Active comparator | Group B will be treated with conventional therapy Participants will perform isometric contraction of the arm at 90° of elevation in the scapular plane. External and internal rotation, respectively) will be performed in the same positions of isometric strength assessment.Individuals will perform three sets, sustained for 32 s, at 70% of maximal voluntary isometric contraction (MVIC), resting for 80 seconds between sets.Resistance load will be determined according to maximal isometric strength of elevation and external and internal rotations measured during the pre-intervention assessment Receives: Other: conventional training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rate scale (NPRS)
Patient level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain".
Measured: 6 weeks
Shoulder pain and disability index (spadi)
Patient level of disability will be assessed using this scale. This ranges from 0 to 100. 0 indicates no disability" and 100 indicates disability"
Measured: 6 weeks
Universal Goniometer (UG)
It will measure range of motion of shoulder
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start15 Apr 2024
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TendinopathyStudies 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
- Model description
- In this parallel- group randomized control trial(RCT) Rotator cuff tendinopathy patients will be assigned to either tendon neuroplastic training or to traditional treatment plan. this study aims to evaluate the effects pf tendon neuroplastic training on pain, range of motion and disability.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saba Rafique, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707857
- Sponsor's protocol ID
- REC/RCR & AHS/24/0111
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 27 Nov 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 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tendon Neuroplastic Training on Pain, Range of Motion and Disability in Patients With Rotator Cuff Tendinopathy
- ClinicalTrials.gov ID
- NCT06707857
- Acronym / sponsor ID
- REC/RCR & AHS/24/0111
- Conditions
- Rotator Cuff Tendinopathy
- Keywords
- Rotator cuff tendiopathy, Tendon neuroplastic training, Disability, Range of motion, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 27 Nov 2024 (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.
EFFECTS OF TENDON NEUROPLASTIC TRAINING ON PAIN, RANGE OF MOTION AND DISABILITY IN PATIENTS WITH ROTATOR CUFF TENDINOPATHY
Detailed description
Rotator cuff tendinopathy is a condition where the shoulder's tendon suffers small tears or inflammation, often causing pain frequently arises from repetitive overuse or the natural aging process Regular overhead activities can aggravate the shoulder's wear and tear, leading to tendinosis. The purpose of this study is to evaluate and compare the impact of tendon neuroplastic training with standard treatments on pain levels, functional disability, and the range of motion in patients suffering from rotator cuff tendinopathy. Data were collected from Riphah rehabilitation clinic Lahore. Nprs , goinmeter and Spadi questioner were used before and after the intervention. Assessment was done through the tool before and after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- In this parallel- group randomized control trial(RCT) Rotator cuff tendinopathy patients will be assigned to either tendon neuroplastic training or to traditional treatment plan. this study aims to evaluate the effects pf tendon neuroplastic training on pain, range of motion and disability.
| Arm | Type | Receives |
|---|---|---|
| Tendon neuroplastic training | Experimental | Other: tendon neuroplastic trainingGroup A will be treated with tendon neuroplastic training. The exercise involved isolated abduction external rotation ,internal rotation and flexion paced to an external audio cue on the patients' smartphone The patient was to listen to the sound and track the movement of the metronome with his eyes, as pacing to these types of external cues has been shown to modulate conspiratorial excitability.The pace of the metronome was set to 6 beats per minute such that each beat was ten seconds apart. This allowed a ten second isometric, eccentric and concentric phase, in 30 seconds totally. Three sets of 10 repetitions of slow progressive exercises (eccentric, concentric and isometric respectively) of the wrist rotator cuff muscles at each treatment session were performed, with 1-min rest interval between each set. The patient followed the supervised exercise programme 3 times a week for 6 weeks |
| Conventional training | Active comparator | Other: conventional trainingGroup B will be treated with conventional therapy Participants will perform isometric contraction of the arm at 90° of elevation in the scapular plane. External and internal rotation, respectively) will be performed in the same positions of isometric strength assessment.Individuals will perform three sets, sustained for 32 s, at 70% of maximal voluntary isometric contraction (MVIC), resting for 80 seconds between sets.Resistance load will be determined according to maximal isometric strength of elevation and external and internal rotations measured during the pre-intervention assessment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a current shoulder complaint lasting at least three months prior to the time of enrollment
- Pain is located in the proximal lateral aspect of the upper arm (C5 dermatome)
- Positive Hawkins-Kennedy test
Key exclusion criteria (9 listed)
- Bilateral shoulder pain
- Less than 90 degrees of active elevation of the arm
- Corticosteroid injection within the last six weeks
- Radiologically verified fracture
- Glenohumeral osteoarthritis
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 |
|---|---|---|
| tendon neuroplastic trainingThroughout the training, participants pain, range of motion and disability were monitored and they were asked to report any discomfort or unusual sign. | Other | Tendon neuroplastic training |
| conventional trainingThroughout the training, participants pain, range of motion and disability were monitored and they were asked to report any discomfort or unusual sign. | Other | Conventional training |
Primary outcome
Numeric pain rate scale (NPRS)
Time frame: 6 weeks
Patient level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain".
Shoulder pain and disability index (spadi)
Time frame: 6 weeks
Patient level of disability will be assessed using this scale. This ranges from 0 to 100. 0 indicates no disability" and 100 indicates disability"
Universal Goniometer (UG)
Time frame: 6 weeks
It will measure range of motion of shoulder
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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Paraplegia, Spinal Cord Injuries
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Comparative Effects of Cyriax Approach With and Without Mobilization With Movement in Shoulder Restriction With Rotator Cuff Tendinopathy
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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.
Saba Rafique, MS-OMPT 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 tendon neuroplastic training and conventional training in people with Rotator Cuff Tendinopathy, 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 9 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: looking for participants now, as of the sponsor's last update on 27 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rate scale (NPRS) (time frame: 6 weeks). The study lists 3 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 27 Nov 2024.