Manual Therapy Combined With Breathing

NCT07180225 | Completed

• 1 other identifier: E-10840098-202.3.02-240-5
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Rotator cuff impingement syndrome is one of the most common causes of shoulder pain and functional limitation, with manual therapy frequently employed in its management. This study aimed to investigate the additional effects of incorporating breathing exercises into manual therapy on pain and function.

Conditions

Rotator Cuff Injuries

Keywords

breathing exercises; manual therapy; conventional therapy

Outcome Measures

Primary Outcomes (4)

• Pain evaluation

  Pain intensity was assesed with visual anaolg scale (VAS) that is a tool commonly used to assess the intensity of musculoskeletal pain. The VAS was used to evaluate the level of shoulder pain experienced by participants at rest, and during activity. Participants were asked to rate their pain intensity on a scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst possible pain." The participants' responses were recorded in the case report forms

  Baseline and 6 weeks

• Disability

  Shoulder Pain and Disability Index (SPADI) is a self-reported, shoulder specific questionnaire developed to assess pain intensity and disability levels in individuals with musculoskeletal shoulder pain.The disability subscale includes eight items, where patients rate the difficulty, they experienced while performing daily activities in the past week, using a scale from 0 (no difficulty) to 10 (so difficult that assistance is required). The total SPADI score was calculated by converting the total raw score into a percentage. The final score ranges from 0 to 100, with higher scores indicating greater levels of pain and disability

  Baseline and 6 weeks

• Range of motion evaluation

  A universal goniometer was used to measure the shoulder joint's ROM in flexion, extension, abduction, internal rotation, and external rotation. Measurements were recorded in degrees. Each movement was performed three times, and the average of these three measurements was used for analysis. After each measurement, the participant returned their arm to the neutral position before the next repetition. The normal ROM values for the shoulder joint are as follows: 0-180° for flexion and abduction, 0-45° for extension and adduction, and 0-90° for internal and external rotation

  Baseline and 6 weeks

• Pulmonary system evaluation

  A firstMed SP-10 electronic handheld spirometer was used to evaluate respiratory function. Each participant was instructed to place a disposable mouthpiece between their lips and teeth, ensuring no air escaped. They were then encouraged to perform a rapid and deep inspiration followed immediately by a forceful and complete expiration. Participants were expected to exhale for at least 6 seconds. The test was terminated once adequate expiration was achieved. Among at least three properly performed consecutive trials, the highest value was recorded

  Baseline and 6 weeks

Study Arms (2)

GROUP I

EXPERIMENTAL

Participants received conventional TENS applied to painful points in the shoulder region. Following TENS, patients performed a physiotherapist-supervised exercise program.At the beginning of the treatment, participants were provided with normal range of motion exercises and isometric strengthening exercises.Also, Glenohumeral joint (GH) distraction, glenohumeral joint inferior gliding, anterior gliding, and posterior gliding, scapulothoracic joint distraction, scapulothoracic joint superior, inferior, medial, and lateral gliding techniques were added.

Other: Conventional therapy+manual therapy

GROUP II

EXPERIMENTAL

In addition to the treatment program applied in Group 1, participants in the intervention group received the following: Glenohumeral joint (GH) distraction, glenohumeral joint inferior gliding, anterior gliding, and posterior gliding, scapulothoracic joint distraction, scapulothoracic joint superior, inferior, medial, and lateral gliding, diaphragmatic breathing exercises, pursed-lip breathing exercises, and relaxation breathing exercises.

Other: Conventional therapy+manual therapy+breathing exercises

Interventions

Conventional therapy+manual therapy OTHER

Conventional therapy contains TENS and physiotherapist-supervised exercise program. These exercises are Wand exercises (15 repetitions each), codman exercises (1 minute in each direction), shoulder wheel exercises (5 minutes total), finger ladder exercises (10 repetitions), isometric exercises (10 repetitions each), capsular stretching exercises (10 repetitions each), pectoral muscle stretching and stabilization exercises (10 repetitions), shoulder stabilization exercises (5 minutes total), and strengthening exercises for the shoulder flexor, extensor, abductor, adductor, internal rotator, and external rotator muscles (15 repetitions each). In addition to them, manual therapy were applied to the shoulder region.

GROUP I

Conventional therapy+manual therapy+breathing exercises OTHER

In addition to the treatment program of Group I, breathing exercises were added. Each manual therapy technique was performed with 10 repetitions per participant. Similarly, participants were instructed to perform each breathing exercise with 10 repetitions. They were also asked to continue the breathing exercises at home, performing them three times a day with 10 repetitions per session for a duration of six weeks.

GROUP II

Eligibility Criteria

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

You may qualify if:

• being between 18 and 65 years of age;
• the presence of at least one of the following clinical findings: positive Neer Impingement Test, positive Hawkins-Kennedy Impingement test, or painful arc during active abduction or flexion
• experiencing pain in at least one of the resisted tests for internal rotation, external rotation, abduction, or flexion
• being able to participate in the face-to-face treatment program consisting of a total of 18 sessions

You may not qualify if:

• a history of upper extremity fracture; undergoing shoulder surgery on the affected side within the past 12 months
• significant shoulder weakness or loss of active shoulder function; the presence of systemic musculoskeletal disorders
• symptom reproduction during active or passive cervical movements; the presence of consciousness disorders, cognitive impairments; and having any diagnosed cardiovascular disease

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Merve Yilmaz Menek

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• MERVE YILMAZ MENEK, PhD

  İstanbul Medipol university

  PRINCIPAL INVESTIGATOR

• ŞULE AYAN

  İstanbul Medipol university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: PARTICIPANTS ARE MASKED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 18, 2025
• Study Start: February 10, 2024
• Primary Completion: July 10, 2024
• Study Completion: July 15, 2024
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

TU (1)