Comparison of ESWT and Deep Tissue Massage in Individuals With Medial Tibial Stress Syndrome

NCT07056426 | Completed

• 1 other identifier: MTSS01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This study, titled "Comparison of the Effectiveness of Extracorporeal Shock Wave Therapy and Deep Tissue Massage in Individuals with Medial Tibial Stress Syndrome (MTSS)," is designed as a prospective, randomized controlled trial with two parallel groups. The research will be conducted at the Sports Health Laboratory of the Ankara Bilkent City Hospital, Department of Physical Medicine and Rehabilitation. The study population will consist of individuals who meet the diagnostic criteria for MTSS and present to the Sports Medicine outpatient clinic. All participants will undergo an exercise program recommended in the literature for the treatment of MTSS. Participants will be randomly assigned into two groups using a sealed-envelope method. One group will receive deep tissue massage in addition to the exercise program, while the other group will receive extracorporeal shock wave therapy (ESWT) alongside the exercises. Additionally, all participants will be treated with conventional transcutaneous electrical nerve stimulation (TENS) at 100 Hz for pain control. Initial assessments, randomization, treatment applications (TENS, exercise, deep tissue massage, and ESWT), and outcome evaluations will be performed by different members of the research team. Outcome assessments will be conducted in a blinded manner to ensure objectivity regarding treatment allocation.

Conditions

Medial Tibial Stress Syndrome

Keywords

Medial Tibial Stress Syndrome; Shin Splint; ESWT; Deep Tissue Massage

Outcome Measures

Primary Outcomes (3)

• Visual Analog Scale

  The intensity of pain in the medial region of the tibia will be measured by the Visual Analog Scale.

  Day 0 (pre-treatment) and Week 3 (post-treatment)

• FAAM

  Foot and Ankle Ability Measure: It is a self-reported scale developed to assess changes in physical function in individuals with musculoskeletal disorders of the foot, ankle, and lower leg, consisting of 29 Likert-type questions scored from 0 to 4 across daily living (21 items) and sports (8 items) subscales, with higher scores indicating better function, and includes additional questions scoring current function from 0 to 100, where 100 represents pre-injury function and 0 indicates inability to perform any normal daily activities.

  Day 0 (pre-treatment) and Week 3 (post-treatment)

• Pain Area

  The length of the painful area along the tibia will be recorded in centimeters.

  Day 0 (pre-treatment) and Week 3 (post-treatment)

Secondary Outcomes (1)

• Pain with Activity

  Day 0 (pre-treatment) and Week 3 (post-treatment)

Other Outcomes (2)

• Navicular Drop Test

  Day 0 (pre-treatment) and Week 3 (post-treatment)

• Foot Posture Index

  Day 0 (pre-treatment) and Week 3 (post-treatment)

Study Arms (2)

ESWT

EXPERIMENTAL

ESWT will be applied once weekly for four sessions, delivering 2000 pulses per session at 2.5 bar pressure and 8 Hz frequency using radial shock waves. Each session's energy flux density is about 200 mJ/mm². The patient will lie supine, with ultrasound gel applied to the medial tibial area. Shock waves will be delivered in a circular motion from medial to lateral, focusing on the most sensitive and painful spot, covering an area approximately 2-4 cm wide and 4-8 cm long.

Other: Exercises; Other: ESWT

Deep Tissue

EXPERIMENTAL

The deep tissue massage will be performed with the patient lying on their side, affected leg on top and knee flexed at about 45 degrees, with the medial tibia facing upward. After applying petroleum jelly, palpation will locate the sensitive medial tibial line. The massage begins with 4-5 superficial strokes along this line, followed by 2-3 deeper strokes to assess muscle tone and sensitivity. Moderate pressure is then applied with the thumb perpendicular to the tibial line, starting just above the medial malleolus and moving slowly toward the medial tibial plateau, before shifting one finger width posteriorly to massage upward along the soleus muscle. These steps are repeated 6-8 times, each lasting 10-15 seconds, with pressure adjusted to a pain level of 7-8 on the Visual Analog Scale (VAS). A 10-second rest is given between applications, and the session ends with 4-5 superficial strokes.

Other: Exercises; Other: Deep Tissue Massage

Interventions

Exercises OTHER

Joint mobilization exercises: -Active ankle range of motion exercises Ankle strengthening with resistance band (Thera-band®): * Resisted dorsiflexion * Resisted plantar flexion * Resisted inversion * Resisted eversion * Leg muscle strengthening exercises: * Heel raises (standing) * Heel raises (sitting) * Toe raises (standing) * Toe raises (sitting) Hip and pelvis stabilizer muscle strengthening exercises: * Pelvic bridge * Side leg lifts with hip and knee at 0° * Side leg lifts with hip and knee at 90° Stretching exercises: * Calf stretch with towel * Gastrocnemius stretch (standing) * Soleus stretch (standing) * Anterior compartment leg stretch These exercises will be applied three times a week in 40-minute sessions, for a total of 12 sessions.

Deep Tissue; ESWT

ESWT OTHER

The Extracorporeal Shock Wave Therapy (ESWT) will be administered once a week for a total of four sessions. Each session will deliver 2000 pulses at a pressure of 2.5 bar and a frequency of 8 Hz using radial shock wave technology. The total energy flux density per session is planned to be approximately 200 mJ/mm². Patients will be positioned in a supine lying position during the treatment. A generous amount of ultrasound gel will be applied to the medial tibial border and surrounding tissues to ensure effective transmission of shock waves and patient comfort. The application of shock waves will follow the clinical focusing principle: treatment will start from the point of greatest tenderness and maximal pain on the medial tibial border, progressing in a circular motion from medial to lateral. The treatment area will typically cover a region approximately 2-4 cm in width and 4-8 cm in length.

ESWT

Deep Tissue Massage OTHER

The deep tissue massage begins with the patient lying on their side, the affected leg on top, knee flexed at about 45 degrees, and the medial surface of the tibia facing upward. The sensitive line along the medial tibia is identified by palpation, and the area is prepared with petroleum jelly. The massage starts with 4-5 superficial strokes along the medial calf using the palm, followed by 2-3 deep strokes to assess muscle tone and patient tolerance. Moderate pressure is applied with the thumb perpendicular to the tibial line, moving slowly from just above the medial malleolus toward the medial tibial plateau. Then, the thumb shifts one finger width posteriorly and moves upward along the soleus muscle with similar pressure. These two steps are repeated 6-8 times, each lasting 10-15 seconds, with pain adjusted to 7-8 on the VAS scale. A 10-second rest is given between applications, and the massage ends with 4-5 superficial strokes.

Deep Tissue

Eligibility Criteria

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

You may qualify if:

• Individuals over 18 years of age,
• Those who participate in recreational or professional level sports,
• Those diagnosed with MTSS

You may not qualify if:

• Those with fracture findings, including radiological stress fractures,
• Those with a history of chronic exercise-related compartment syndrome,
• Those who have previously received ESWT (extracorporeal shock wave therapy) or deep tissue massage treatment for MTSS,
• Those with rheumatologic diseases (such as rheumatoid arthritis, widespread polyarthritis, etc.),
• Those with local infection or tumor in the treatment area,
• Pregnant women,
• Those with bleeding disorders,
• Those with advanced-stage ipsilateral knee and ankle osteoarthritis (defined by severe joint space narrowing, joint sclerosis, and periarticular osteophytes),
• Those who have received local injection (e.g., corticosteroids) in the treatment area within the last 3 months,
• Those who have previously undergone knee or ankle surgery.

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead
• Ankara City Hospital Bilkent: collaborator

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Medial Tibial Stress Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pricipal Investigator

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: July 9, 2025
• Study Start: June 2, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 23, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

TU (1)