The Effect of the Treatment Environment on Pain, Function, Self Efficacy and Satisfaction in RCRSP

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorIstanbul University - Cerrahpasa

About this trial

Brief Summary

The aim of this randomized controlled study is to reveal the short-term effects of physical and social factors in different therapeutic environments on patients with rotator cuff related shoulder pain following the same exercise program. The main questions it aims answer are:

* Is there any difference in terms of pain levels among groups with rotator cuff related shoulder pain who treated in different therapeutic settings. * Is there any difference in terms of functionality and self-efficacy among groups with rotator cuff related shoulder pain who treated in different therapeutic settings.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-75 years old

diagnosed with impingement syndrome, subacromial bursitis, rotator cuff tendinopathy or partial rotator cuff tear

pain level between 3-7 according to visual analog scale

pain persisted for at least 3 months

Disqualifiers

having a full-thickness or massive rotator cuff tear

history of shoulder surgery

having a musculoskeletal disease that prevents exercise

having a neurological disease or psychological disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Patient Education

    Behavioral

    It includes evaluation of the treatment process and past sessions. Simple shoulder biomechanics, function, and what caused the injury were explained to the patients. In order to increase patients' participation in treatment, it was emphasized what the treatment does and that the patient should cooperate in order to heal. During their treatment, patients are instructed to regulate their daily living activities, avoid overhead and repetitive movements of the arm, bags weighing more than 2-3 kg, etc. It was recommended not to carry them. Patients were informed about alternative sleeping positions.

  • Exercise Therapy

    Behavioral

    Participants in both groups were included in a structured exercise program consisting of exercises recommended in the literature. This exercise program includes joint range of motion exercises, stretching exercises and strengthening exercises and was carried out under the supervision of a physiotherapist for 6 weeks. Joint range of motion and strengthening exercises are recommended as 3 sets of 10 repetitions, and stretching exercises are recommended as 5 repetitions for 20 seconds. Exercises appropriate to the patients' clinical conditions and progression were selected by the physiotherapist and included in the program.

  • Cold Application

    Behavioral

    Following each exercise treatment, cold-pack will be applied for 15 minutes. During col-pack application, patients in the Group 1 group will listen to classical music selected by us, while patients in the Group 2 will rest quietly. There are a total of 40 songs by Bach, Mozart, Beethoven and Andre Rieu on our CD player, and patients have the right to choose and listen to the song they want.

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: The enriched therapeutic environment group (Group 1)Experimental treatment 3 interventions
Group B: The isolated therapeutic environment group (Group 2).Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Numeric Pain Rating Scale (NPRS)

Participants' pain at rest, at night and during activity was measured using the NPRS. The NPRS is an 11-point scale that can be scored from 0 to 10. A score of zero (0) indicates "no pain" and 10 indicates score defines "the most severe pain". The patient will be asked to mark shoulder pain on the scale

Time frame
Baseline, 3rd week, 6th week

Secondary outcomes

1

Quick - The Disabilities of the Arm, Shoulder and Hand (Quick DASH) Questionnaire

Q-DASH is a questionnaire developed to assess upper extremity functioning and symptoms based on self-report of patients. The total score of the scale ranges from 0-100 points and similar to SPADI, a high score is considered as high functional disability.

Time frame
Baseline, 3rd week, 6th week, 12th week
2

Western Ontario Rotator Cuff (WORC) Index

WORC is a functional test which consists of 5 sections and a total of 21 questions assessing the physical symptoms, sports/leisure time activities, work, lifestyle, emotions that are affected by the shoulder problem. Each question is rated on a scale of 0-100 mm. Patients are scored between 0 and 2100 in total, with 2100 being the worst score.

Time frame
Baseline, 3rd week, 6th week, 12th week
3

Pain Self-Efficacy Questionnaire (PSEQ)

The Pain and Self-Efficacy questionnaire consists of 10 questions and it assesses multiple domains of self-efficacy related to social and physical functioning. Each item is rated on a 7-point Likert-type scale (0: I am not at all confident, 6: I am completely confident). The total score ranges from 0 to 60, with higher scores indicating greater self-efficacy for functioning despite pain.

Time frame
Baseline, 3rd week, 6th week, 12th week
4

Global Rating of Change, GRC

The Global Rating of Change (GRC) is specifically designed to determine the impact of an intervention in musculoskeletal problems, to chart the clinical course of a condition and to measure a patient's improvement or deterioration over time. When using the GRC scale, the patient being assessed must have a certain cognitive level because the patient's ability to recall and measure the pre-treatment state is required. In our study, a scale consisting of 5 levels will be used (-2: much worse, -1: worse, 0: same, 1: better, 2: much better).

Time frame
Baseline, 3rd week, 6th week, 12th week

Other outcomes

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