Comparison of SEP Exercises Versus SSMP With Tendon Loading & Resistance Exercise in Shoulder Pain.

NCT05408949 | Completed

• 1 other identifier: IRB/COHS/STD/06/Jan-2022
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

Brief Summary

Shoulder pain is one of the most prevalent and disabling musculoskeletal condition. A new diagnostic terminology used to describe shoulder pain is rotator cuff-related shoulder pain (RCRSP), as histological findings were similar in many of shoulder condition such as; subacromial impingement syndrome, subacromial pain syndrome and rotator cuff tendinopathy The objectives was to find the effectiveness of single exercise into pain program versus Shoulder Symptom Modification Procedure (SSMP) with early tendon loading, Heavy Slow Resistance exercise in patients with rotator cuff-related shoulder pain. The investigators will conducted a randomized clinical trail in out patient physiotherapy department at Thumbay hospitals Ajman, in patients with rotator cuff-related shoulder pain . After meeting the inclusion criteria, participants were randomized into Single exercises into pain program (SEP) (intervention group) or Shoulder Symptom Modification Procedure (SSMP) with early tendon loading, Heavy Slow Resistance exercise program (control group). A 13 weeks of outpatient musculoskeletal rehabilitation sessions consisting of 3 sessions per week will provided to both the groups. Intervention group will receive single exercises into pain by preforming resisted isometric shoulder abduction with TheraBand and progressed to functional rehabilitation, whereas control group will receive a combination of shoulder symptom modification to control the pain, early tendon loading to target the series elastic component of the muscle and heavy slow resistance program to target contractile component of the muscles and improve mechanical strength followed by functional rehabilitation. The investigators will measured Shoulder Pain and Disability Index (SPADI), Numerical Pain Rating Scales (NPRS), and Digital Wall (D-WALL) H-Sport Quality Of Life at the baseline assessment, 6th weeks and 13th weeks

Conditions

Subacromial Pain Syndrome

Keywords

Subacromial pain syndrome, Rotator cuff tendinopathy

Outcome Measures

Primary Outcomes (4)

• The Shoulder Pain and Disability Index (SPADI)

  SPADI is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. The change in SPADI scores are assessed. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.

  Day 1 of enrollment session and end day of 6th week, change in SPADI scores are assessed

• Numerical Pain Rating Scales (NPRS)

  NPRS will be used to identify the intensity of the participants pain at the baseline, 6th week, and 13th week at rest, activity, night, maximum and the results will be reported. In NPRS, the participants are asked to draw a circle on the number between zero to ten. Zero will represent "no pain at all", ten will represents "'the worst pain ever possible. The change is pain scores are assessed

  Day 1 of enrollment session and end day of 6th week, change in NPRS scores are assessed

• The Shoulder Pain and Disability Index (SPADI)

  SPADI is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. The change in SPADI scores are assessed. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.

  End of 6th week and end of 13th week, change in SPADI scores are assessed

• Numerical Pain Rating Scales (NPRS)

  NPRS will be used to identify the intensity of the participants pain at the baseline, 6th week, and 13th week at rest, activity, night, maximum and the results will be reported. In NPRS, the participants are asked to draw a circle on the number between zero to ten. Zero will represent "no pain at all", ten will represents "'the worst pain ever possible. The change is pain scores are assessed.

  End of 6th week and end of 13th week, change in NPRS scores are assessed

Secondary Outcomes (2)

• Digital Wall (D-WALL) H-Sport

  Time Frame: From the start of treatment i.e., Day 1, Base line assessment, 6th week and 13th week of therapy session

• Patient Global Impression of Change (PGIC)

  Time Frame: From the start of treatment i.e., Day 1 and 13th week of therapy session

Study Arms (2)

SEP+FR

EXPERIMENTAL

\- Single exercises program (SEP) is considered to be harmless, valid and has a valuable prescription as initial rehabilitation program. studies showed an immediate analgesic relief and increase in muscle strength after preforming single heavy-load isometric training program

Behavioral: Single exercise into pain (SEP) program; Behavioral: Functional Rehabilitation Program

SSMP+ETL+HSR+FR Group

ACTIVE COMPARATOR

* The Shoulder Symptom Modification Procedure (SSMP) consists of applying several mechanical techniques and applied when the patient moves or performs a specific activity. This procedure is designed to address the symptoms and improve range of motion by identifying mechanical changes. * Heavy slow resistance (HSR) training is an alternative from traditional exercise physiotherapy, by emphasizing on heavy weights and slow repetition. HSR training includes repetitive gradual and slow contraction of the muscle during concentric, isometric and eccentric phases against a heavy weight * Early controlled and progressive tendon loading (EPTL) in rehabilitation practice is suggested to show a high and definite impact on healing and recovery of the tendon

Behavioral: Shoulder Symptom Modification Procedure (SSMP); Behavioral: Functional Rehabilitation Program; Behavioral: EPTL; Behavioral: HSR

Interventions

Single exercise into pain (SEP) program BEHAVIORAL

* Baseline assessment \& commencement of treatment: Resisted isometric shoulder abduction into pain (or lateral rotation or flexion into pain) against a wall, or Resisted shoulder abduction from 0 to 30° using moderate resistance from Theraband ( Prescribed High intensity loading to the tendon (85-90% iMVC) applied in 5 repetitions with a 45 secoud hold (3 times per week)). * Initial follow-up \& progression: Resisted shoulder abduction into pain from 80 to 120° using light weight (Prescribed High intensity loading to the tendon (85-90% iMVC) applied in 5 repetitions with a 45 secoud hold (3 times per week)). * Second follow-up \& progression: eccentric shoulder abduction into pain from 80 to 120° with progressively increasing repetition and weight, e.g. heavy Theraband or dumbbell. * Final assessment to identify any non-resolved functional limitations and progress eccentric exercises into pain as required * Functional rehabilitation program

SEP+FR

Shoulder Symptom Modification Procedure (SSMP) BEHAVIORAL

\[1\] Finger on the sternum,\[2A\] Scapula modification \[3\] 'Humeral head' modification \[4\] Isometric (most painful movement) Heavy slow resistance (HSR): start from the mid-range and pain-free

SSMP+ETL+HSR+FR Group

Functional Rehabilitation Program BEHAVIORAL

Mostly targetted into exercise such as multi-stage pushing, pulling, lifting and carrying, throwing, kinetic chain exercises and aerobics. FR involved (i). Weight-shifting activities to enhance dynamic joint stability\[18\] .(ii). Proprioceptive neuromuscular facilitation exercises to stimulating stretch receptors located on the muscle or tendon units \[18\]. Using resistive tubing exercises in a functional position using PNF patterns; diagonal pattern 1: flexion, abduction, external rotation (10-15 repetition 2-3 sets). (iii) Plyometric exercise: (A) throwing motions; (B) push-up (10-15 repetition 2-3 sets) . (iv). Table slide (10-15 repetition 2-3 sets).

SEP+FR; SSMP+ETL+HSR+FR Group

EPTL BEHAVIORAL

In EPTL it involves eccentric training in Full range (with dumbbells 15-10 RM) of Internal and external rotation at scapular plane elevation (0-45) degree and Flexion, Abduction, in full range (5 repetitions with a 45 second hold at slow speed) to target the series elastic component of the muscle .

SSMP+ETL+HSR+FR Group

HSR BEHAVIORAL

In HSR it involves eccentric training in mid-range of motion (with dumbbells 15-10 RM) targeting the contractile component of the muscles and improving mechanical strength. Additionally, when there is 90% pain reduction on NPRS functional rehabilitation program start and they follow the same program as Group A.

SSMP+ETL+HSR+FR Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 to 60 years old
• Rotator Cuff tendinitis, tendinopathy and impingement syndrome
• Acute and chronic conditions
• Self-reported pain or symptoms localized around the shoulder, and not referred below the elbow
• Willing and able to participate, provide consent process

You may not qualify if:

• Inability to communicate or provide informed consent.
• History of unstable fracture/dislocation in upper extremities with shoulder instabilities
• Referred pain to shoulder from other area
• Adhesive capsulitis
• Any surgical history on shoulder and neck

Sponsors & Collaborators

• Gulf Medical University: lead

Study Sites (2)

Gulf Medical University, Thumbay Physical Therapy and Rehabiliation Hospital, Thumbay University Hospital

Ajman, United Arab Emirates

Location

Gulf Medical University

Ajman, United Arab Emirates

Location

Study Officials

• Dr. Ramprasad Muthukrishnan, Ph.D

  College of Health Sciences, Department of Physiotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double (participant, investigators) blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial 13-weeks parallel non-inferiority study

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 7, 2022
• Study Start: January 27, 2022
• Primary Completion: December 20, 2022
• Study Completion: January 30, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

AE (2)