Clinical trial NCT05408949: Comparison of SEP Exercises Versus SSMP With Tendon Loading & Resistance Exercise in Shoulder Pain.
Official title: Effectiveness of Single Exercise Into Pain Program Versus Shoulder Symptom Modification Procedure With Early Tendon Loading, Heavy Slow Resistance Exercise in Patients With Rotator Cuff-related Shoulder Pain: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Pain Syndrome
Keywords: Subacromial pain syndrome, Rotator cuff tendinopathy
Lead sponsor: Gulf Medical University
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial 13-weeks parallel non-inferiority study
Primary purpose: TREATMENT

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

Detailed description: The Shoulder Symptom Modification Procedure (SSMP) is a series of mechanical techniques that are applied while the patient performs the activity or movement, with the aim of identifying a mechanical change that will alleviate and treat the symptoms and improve range of motion. This process involves identifying the movement, posture, or activity that reduces the patient's symptoms. SSMP is designed to identify a positive effect on symptoms by providing changes in position of the glenohumeral or scapulothoracic joints or thoracic spine. Besides, SSMP perhaps impact the symptoms related with RCRSP by altering rotator cuff muscle-tendon tension, changing the anatomical structure, and releasing the neuromodulation. Using Shoulder Symptom Modification Procedure (SSMP) can inspect the effect of thoracic spine posture, scapula posture in three different anatomical planes, and position of humeral head on shoulder joint symptoms. Moreover, it provides immediate direction for selecting one or more methods among the four mechanical techniques for treating RCRSP. The main goal of SSMP to treat, decrease symptoms and/or improving function and movement.

Heavy slow resistance (HSR) training program includes repetitive gradual and slow contraction of the muscle during concentric, isometric and eccentric phases against a heavy weight, i.e., 1RM. In previous studies it was proven that the HSR training program used for a plantar fasciopathy was found to have superior results than stretching. Demonstrating Heavy Slow Resistance in eccentric form will target the contractile component of the muscles and improve mechanical strength. Besides HSR training is an alternative from traditional exercise physiotherapy, by emphasizing on heavy weights and slow reptation. Without sufficient power the muscle and tendons will have poor strength and endurance. A suggestion of static, sustain load with 5 reptation and 45 second hold, repeated 2-3 times per week will provide a beneficial outcome. Only one recent study showed a 15% increase in abduction due to adding heavy load eccentric training for individuals with unilateral subacromial impingement.

Administration of 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. In addition, there are various benefits related to EPTL, new evidence showed it help accelerates healing, alleviate joint restriction, and reduce the risk of re-tearing. Moreover, it has been stated that load exercises for mid-tendon or at the insertion sites of the Achilles tendon provide a better clinical outcome in any parts of the tendon. Besides, preforming isometrics in mid-range can reduce the pain in tendinopathy rehab progression.

Furthermore, single exercises into pain (SEP) program is considered to be harmless, valid and has a valuable prescription as initial rehabilitation program. A recent study discussed the tendinopathy in lower limbs showed an immediate analgesic relief and increase in muscle strength after preforming single heavy-load isometric training program. Pain can be better used for navigate the symptom management to foster recovery. A "Traffic Light Pain Control graph" where a score of 3 out of 10 pain level is a good area to practice the exercise. In addition, a score of 4 out of 10 isn't harmful or can cause any damage. Although pain level should be tolerable and isn't increasing the next day. Additionally in Reactive tendinopathy/early tendon disrepair level, the load management helps the matrix of the tendon to resume a more normal structure. However, the clinical effectiveness of SEP on shoulder conditions is still sparce.

Daily functional rehabilitation (FR) is needed for the individual with RCRSP to provide self-independence after the initial phases of physiotherapy. In the functional activity, daily living or sporting activities of the individuals are incorporated in an exercise form to train and facilitate pain free and efficient daily movement contingencies. a daily functional rehabilitation is needed to avoid any future harm, along with restoring the individuals to their best physical fitness statues. Core stabilization, postural alignment kinetic chain, scapular position, range of motion, pain and cardiovascular training are the main stay of current functional rehabilitation regimes. However little or no research studying the efficacy of functional training programs on the improvement of clinical outcomes of RCRSP. The fundamental reason for this research is that rotator cuff-related shoulder pain can cause a major complication with substantial implication on well-being. A study needed to be conducted to fuel the necessary advances in a newly approaches discovered recently to address and evaluate the clinical effectiveness of above approaches.

Comparing these interventions may provide vital clues for shoulder rehabilitation in the management of RCRSP

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: The Shoulder Pain and Disability Index (SPADI)
timeFrame: Day 1 of enrollment session and end day of 6th week, change in SPADI scores are assessed
measure: Numerical Pain Rating Scales (NPRS)
timeFrame: Day 1 of enrollment session and end day of 6th week, change in NPRS scores are assessed
measure: The Shoulder Pain and Disability Index (SPADI)
timeFrame: End of 6th week and end of 13th week, change in SPADI scores are assessed
measure: Numerical Pain Rating Scales (NPRS)
timeFrame: End of 6th week and end of 13th week, change in NPRS scores are assessed
Secondary outcomes:
measure: Digital Wall (D-WALL) H-Sport
timeFrame: Time Frame: From the start of treatment i.e., Day 1, Base line assessment, 6th week and 13th week of therapy session
measure: Patient Global Impression of Change (PGIC)
timeFrame: Time Frame: From the start of treatment i.e., Day 1 and 13th week of therapy session
Other outcomes:
Locations:
city: Ajman
country: United Arab Emirates
facility: Gulf Medical University, Thumbay Physical Therapy and Rehabiliation Hospital, Thumbay University Hospital
city: Ajman
country: United Arab Emirates
facility: Gulf Medical University
Study officials:
affiliation: College of Health Sciences, Department of Physiotherapy
name: Dr. Ramprasad Muthukrishnan, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: