Istanbul Medipol University
Istanbul, 34815, Turkey (Türkiye)
Location contact
Burak Menek, PhD
CONTACT
Emre DANSUK, Phd
PRINCIPAL_INVESTIGATOR
Emre Dansuk, PhD
CONTACT
NCT Number: NCT07756203
This assessor-blinded, three-arm, parallel-group randomized controlled trial will investigate the additional effects of percussion massage therapy and instrument-assisted soft tissue mobilization in individuals with subacromial impingement syndrome. Forty-eight participants aged 40-60 years with clinically and magnetic resonance imaging-confirmed subacromial impingement syndrome will be randomly allocated in a 1:1:1 ratio to conventional physiotherapy, percussion massage therapy plus conventional physiotherapy, or instrument-assisted soft tissue mobilization plus conventional physiotherapy.
All groups received a standardized four-week conventional physiotherapy programme. Participants in the percussion massage therapy and instrument-assisted soft tissue mobilization groups additionally received their respective interventions three times per week for four weeks. Outcomes were evaluated at baseline and immediately after the four-week intervention. The primary outcome was shoulder joint position sense during flexion and abduction. Secondary outcomes were shoulder range of motion, resting and activity-related pain, upper-extremity disability, and rotator cuff-related quality of life.
Trial opening soon.
Get Notified40 year–60 year
All sexes
Interventional
Not applicable
Istanbul, 34815, Turkey (Türkiye)
Burak Menek, PhD
CONTACT
Emre DANSUK, Phd
PRINCIPAL_INVESTIGATOR
Emre Dansuk, PhD
CONTACT
Subacromial impingement syndrome is commonly associated with shoulder pain, limitations in range of motion, functional disability, and impaired sensorimotor control. Exercise-based rehabilitation is considered a primary component of conservative management. Percussion massage therapy and instrument-assisted soft tissue mobilization are frequently used as adjunct soft-tissue interventions; however, comparative evidence regarding their additional effects in individuals with subacromial impingement syndrome remains limited.
This study will be conducted as a parallel-group, assessor-blinded randomized controlled trial with a 1:1:1 allocation ratio. Forty-eight eligible participants will be randomly allocated to one of three groups: conventional physiotherapy, percussion massage therapy plus conventional physiotherapy, or instrument-assisted soft tissue mobilization plus conventional physiotherapy.
The randomization sequence will be computer-generated using Randomizer.org by an independent researcher who will not be involved in participant recruitment, intervention delivery, or outcome assessment. Because of the nature of the interventions, blinding of participants and treating physiotherapists will not be possible. Outcome assessments will be conducted by an independent physiotherapist who will be blinded to group allocation. Statistical analyses will be performed by a biostatistician who will be blinded to the coded group assignments.
All participants will receive a standardized conventional physiotherapy programme for four weeks. Participants assigned to the percussion massage therapy and instrument-assisted soft tissue mobilization groups will additionally receive the corresponding soft-tissue intervention three times per week for four weeks.
Outcome assessments will be performed at baseline and immediately after completion of the four-week intervention. The primary outcome will be shoulder joint position sense during flexion and abduction. Secondary outcomes will include shoulder range of motion, resting and activity-related pain, upper-extremity disability, and rotator cuff-related quality of life.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Percussion massage therapy will be administered using a handheld Hypervolt device (Hyperice, California, USA) at 33 Hz, corresponding to level 2 of the device. A flat-head attachment will be used to provide uniform contact with the treated tissues.
The intervention will be applied to the deltoid, supraspinatus, infraspinatus, and teres minor muscles along their anatomical fibre orientation. Each muscle will be treated for three minutes using controlled longitudinal strokes applied alternately in proximal-to-distal and distal-to-proximal directions. The intervention will last 12 minutes per session and will be administered by the same licensed physiotherapist three times per week for four weeks. It will be provided in addition to the 30-minute conventional physiotherapy programme, resulting in a total session duration of 42 minutes.
Other names: Hypervolt Percussion Massage Device
Instrument-assisted soft tissue mobilization will be administered to the deltoid, supraspinatus, infraspinatus, and teres minor muscles three times per week for four weeks. All applications will be performed by the same licensed physiotherapist.
Standardized sweep and brush stroke techniques will be applied at an approximate treatment angle of 45° according to the anatomical fibre orientation of each muscle. For each muscle, 90 seconds of parallel strokes will be followed by 90 seconds of perpendicular strokes using controlled sweeping movements. The intervention will last three minutes per muscle and 12 minutes per session. It will be provided in addition to the 30-minute conventional physiotherapy programme, resulting in a total session duration of 42 minutes.
Other names: IASTM
Participants will receive supervised conventional physiotherapy from a licensed physiotherapist five times weekly for four weeks. Each standard 30-minute session will include 20 minutes of TENS to the symptomatic shoulder at 100 Hz and 10 minutes of exercise. Exercises will comprise wand-assisted shoulder movements, Codman pendulum exercises, active and passive stretching, finger-ladder exercises, and elastic-band strengthening for flexion, abduction, extension, and internal and external rotation. Exercises will be performed for 10 repetitions per set, with resistance progressed according to pain, function, and tolerance. To match treatment duration and therapist contact, the control group will perform an additional standardized 12-minute exercise block during three sessions weekly, including one extra set of range-of-motion and resistance exercises. Sessions will therefore last 42 minutes on three days and 30 minutes on two days weekly.
Time frame: Baseline and immediately after the 4-week intervention
Shoulder joint position sense will be assessed using a digital goniometer at target positions of 60° of shoulder flexion and 60° of shoulder abduction. The affected shoulder will be passively positioned at the target angle, and the participant will be allowed up to 10 seconds to memorize the position. The arm will then be returned to the neutral position, and the participant will be asked to actively reproduce the target position with their eyes closed.
The absolute angular difference between the target position and the reproduced position will be calculated in degrees. Three trials will be conducted for flexion and three trials for abduction, and the mean absolute error for each direction will be used in the analysis. Lower values will indicate greater joint position sense accuracy.
Time frame: Baseline and immediately after the 4-week intervention
Active shoulder range of motion will be measured in degrees using a digital goniometer under standardized assessment conditions. Shoulder flexion, abduction, internal rotation, and external rotation will be assessed. Higher values will represent greater shoulder range of motion.
Time frame: Baseline and immediately after the 4-week intervention
Resting and activity-related shoulder pain intensity will be assessed separately using a 10-centimetre Visual Analog Scale. The scale will be anchored by 0, indicating no pain, and 10, indicating the worst imaginable pain. Participants will mark their pain intensity on the scale, and the distance from the zero anchor will be measured in centimetres. Lower scores will indicate lower pain intensity.
Time frame: Baseline and immediately after the 4-week intervention
Upper-extremity disability will be assessed using the Disabilities of the Arm, Shoulder, and Hand questionnaire. The questionnaire contains 30 items and generates a total score ranging from 0 to 100. Higher scores will indicate greater upper-extremity disability, whereas lower scores will indicate better function.
Time frame: Baseline and immediately after the 4-week intervention
Rotator cuff-related quality of life will be assessed using the Rotator Cuff Quality of Life questionnaire. The questionnaire contains 34 items covering physical symptoms, work, daily activities, social functioning, and emotional well-being. Scores will be expressed on a scale from 0 to 100, with higher scores indicating better rotator cuff-related quality of life.
Contact information is provided by the study sponsor or research team.
Emre DANSUK
Other
Comparative Effects of Percussion Massage Therapy and Instrument-Assisted Soft Tissue Mobilization as Adjuncts to Conventional Physiotherapy in Subacromial Impingement Syndrome: A Randomized Controlled Trial
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