NCT06707857

Brief Summary

EFFECTS OF TENDON NEUROPLASTIC TRAINING ON PAIN, RANGE OF MOTION AND DISABILITY IN PATIENTS WITH ROTATOR CUFF TENDINOPATHY

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

April 15, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

November 25, 2024

Last Update Submit

November 25, 2024

Conditions

Keywords

Rotator cuff tendiopathyTendon neuroplastic trainingDisabilityRange of motionPain

Outcome Measures

Primary Outcomes (3)

  • 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".

    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"

    6 weeks

  • Universal Goniometer (UG)

    It will measure range of motion of shoulder

    6 weeks

Study Arms (2)

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

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

Other: conventional training

Interventions

Throughout the training, participants pain, range of motion and disability were monitored and they were asked to report any discomfort or unusual sign.

Tendon neuroplastic training

Throughout the training, participants pain, range of motion and disability were monitored and they were asked to report any discomfort or unusual sign.

Conventional training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Symptomatic arthritis in the Ac joint
  • Frozen shoulder
  • Symptoms derived from the cervical spine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabilitation clinic

Lahore, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Saba Rafique, MS-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study was single blinded, as accessor of the study were kept blind to the intervention groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2024

First Posted

November 27, 2024

Study Start

April 15, 2024

Primary Completion

December 1, 2024

Study Completion

January 1, 2025

Last Updated

November 27, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations