Effects of Knowledge of Results Intervention in Rotator Cuff-Related Shoulder Pain

NCT07632729 | Enrolling By Invitation DMC

• 1 other identifier: FTREK26/28
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Previous research demonstrates that augmented feedback effectively enhances motor skills and performance in both healthy individuals and those with neurological conditions. However, while the role of Knowledge of Results (KR)-a specific augmented feedback strategy-in supporting motor learning is well-established, its efficacy in improving rehabilitation outcomes remains unclear. Notably, there is a lack of studies in the current literature investigating the effects of augmented feedback strategies in individuals with rotator cuff-related shoulder pain (RCRSP). Given the complex and multidimensional pain neurophysiology associated with RCRSP, a KR intervention is hypothesized to hold significant potential for restoring motor control, correcting pain-driven maladaptive movement patterns, alleviating pain, and recovering function in this population. Therefore, the primary objective of this study is to investigate the effects of a KR intervention on clinical outcomes, physical performance, and psychosocial parameters in individuals with RCRSP. The study is designed as a two-arm, prospective, parallel-group, randomized controlled trial. Eligible participants meeting the inclusion criteria will be randomly allocated to either the intervention (n = 28; standard rehabilitation program+ KR intervention)or control group (n = 28; standard rehabilitation program) using computer-based randomization software (www.sealedenvelope.com). Both groups will undergo the same routine exercise-based treatment protocol over an 8-week period, consisting of one physiotherapist-supervised session per week and a home exercise program on the remaining days. While the control group will solely receive the standard rehabilitation program, the intervention group will additionally receive the KR intervention, wherein their assessment results will be regularly shared throughout the treatment process. Conversely, these data will only be disclosed to the control group participants at the conclusion of the 8-week intervention.

Conditions

Augmented Feedback; Rotator Cuff-related Shoulder Pain; Rehabilitation

Keywords

augmented feedback; knowledge of results; rotator cuff; shoulder pain; rehabilitation

Outcome Measures

Primary Outcomes (2)

• Pain Intensity

  Participants' pain intensity at rest, at night, and during activity will be evaluated using the Visual Analog Scale (VAS). The VAS consists of a 10-cm continuous horizontal line, anchored by "0 = no pain" at the left extremity and "10 = worst imaginable pain" at the right extremity. Participants will be instructed to place a mark on the line that corresponds to their perceived level of pain.

  Baseline, up to 8 weeks, at 8 weeks

• Disability

  Participants' disability levels will be evaluated using The Shoulder Pain and Disability Index (SPADI). SPADI is a self-reported questionnaire designed to assess pain severity and the level of functional limitation in activities of daily living among individuals experiencing shoulder pain. The instrument consists of a total of 13 items divided into two subscales: pain (5 items) and disability (8 items). Each item is evaluated using a visual analog scale ranging from 0 (no pain or no difficulty) to 10 (worst imaginable pain or extreme difficulty).

  Baseline, up to 8 weeks, at 8 weeks

Secondary Outcomes (10)

• Perceived Recovery

  Baseline, up to 8 weeks, at 8 weeks

• Range of Motion

  Baseline, up to 8 weeks, at 8 weeks

• Shoulder Muscle Strength

  Baseline and at 8 weeks

• Proprioception

  Baseline and at 8 weeks

• Posterior Shoulder Endurance

  Baseline and at 8 weeks

Study Arms (2)

Standart rehabilitation + Knowledge of Results

EXPERIMENTAL

All participants will undergo an 8-week standard shoulder rehabilitation program comprising patient education, manual therapy, and structured progressive exercise. In addition to this standard protocol, the intervention group will receive a KR intervention, administered immediately prior to each weekly supervised session. Accordingly, parameters routinely assessed before each session-namely, pain intensity (VAS), disability level (SPADI), active and pain-free range of motion, isometric external rotation strength, and the Global Rating of Change (GROC)-will be analyzed in real-time. Immediately following the completion of these assessments, the physiotherapist will verbally and numerically communicate the current measurement results to the patient, alongside the absolute change recorded compared to the previous week. To ensure the patient's full attention is directed toward the data, this feedback will be delivered using a clear and emphasized tone of voice.

Behavioral: Knowledge of Results; Other: Standart Rehabilitation

Standart rehabilitation

ACTIVE COMPARATOR

Participants allocated to the control group will solely undergo the standard 8-week shoulder rehabilitation program, which comprises patient education, targeted manual therapy, and the structured progressive exercise regimen, identical to the intervention group. Although these participants will attend the same weekly supervised sessions and undergo the exact same routine pre-session assessments-including pain intensity (VAS), disability level (SPADI), active and pain-free range of motion, isometric external rotation strength, and the Global Rating of Change (GROC)-they will not receive the Knowledge of Results (KR) intervention. All clinical and physical performance data will only be disclosed to the control group participants upon the full completion of the 8-week intervention period.

Other: Standart Rehabilitation

Interventions

Knowledge of Results BEHAVIORAL

Knowledge of Results (KR) is an augmented feedback strategy designed to provide patients with objective, quantifiable data regarding their clinical and physical progress. In this study, the KR intervention will be administered weekly, immediately prior to each supervised treatment session. After the completion of routine pre-session assessments (including pain intensity, disability level, range of motion, isometric strength, and GROC), the physiotherapist will verbally and numerically communicate the patient's current scores, alongside the absolute change recorded compared to the previous week. To maximize the patient's focus on their cumulative recovery, this feedback will be delivered directly and explicitly using a clear, emphasized tone of voice. For example, "your pain level this week is 4 out of 10, which is a 10% decrease compared to last week".

Standart rehabilitation + Knowledge of Results

Standart Rehabilitation OTHER

Participants allocated to the control group will solely undergo the standard 8-week shoulder rehabilitation program, which comprises patient education, targeted manual therapy, and the structured progressive exercise regimen, identical to the intervention group. To isolate the effects of the augmented feedback, the physiotherapist will strictly withhold the current measurement results and any information regarding their weekly progress.

Standart rehabilitation; Standart rehabilitation + Knowledge of Results

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 35 years;
• Presence of unilateral shoulder pain lasting for at least 3 months;
• Confirmed diagnosis of at least one of the following conditions by a physician, based on clinical evaluation and magnetic resonance imaging (MRI) or ultrasonography (USG) findings: subacromial impingement syndrome, subacromial bursitis, rotator cuff tendinopathy, or partial rotator cuff tear (\< 1 cm);
• Presence of a positive painful arc during flexion or abduction, at least one positive impingement test (Neer or Hawkins-Kennedy), and provocation of symptoms during resisted humeral external rotation, abduction, or scapular plane elevation at 90° of elevation;
• A physical activity score of 5 or higher according to the Tegner Activity Level Scale.

You may not qualify if:

• Presence of bilateral shoulder pain;
• Presence of a full-thickness or massive rotator cuff tear;
• History of shoulder trauma, fracture, or instability;
• Restriction in passive range of motion;
• Receipt of any injection to the shoulder joint within the previous 6 weeks;
• History of previous shoulder surgery or dislocation;
• Pregnancy;
• Presence of cervical radiculopathy symptoms or peripheral nerve entrapment syndromes;
• A score of 14 or higher on the Beck Depression Inventory-II;
• Diagnosis of hypertension, cardiovascular disease, peripheral vascular disease, history of deep vein thrombosis, neurological disorders, systemic inflammation, diabetes, cancer, or rheumatological diseases;
• Presence of obesity or metabolic syndrome;
• Participation in any rehabilitation program for a shoulder problem within the past year;
• Unwillingness to participate in the study (or failure to provide informed consent).

Sponsors & Collaborators

• Elif Turgut: lead

Study Sites (1)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation,, Ankara, Sıhhıye 06100

Ankara, Sıhhıye, 06100, Turkey (Türkiye)

Location

Related Publications (1)

• Moinuddin A, Goel A, Sethi Y. The Role of Augmented Feedback on Motor Learning: A Systematic Review. Cureus. 2021 Nov 18;13(11):e19695. doi: 10.7759/cureus.19695. eCollection 2021 Nov.

  PMID: 34976475 RESULT

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to their group allocation and are kept naive to the specific details of the alternative treatment protocol.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, PT

Model Details: A two-arm, prospective, parallel-group randomized controlled trial

Study Record Dates

• First Submitted: May 16, 2026
• First Posted: June 8, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)