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

Ankara Yildirim Beyazıt University

Status: Active, not recruiting

Conditions: Medial Tibial Stress Syndrome

Treatments: Other: Exercises; Other: Deep Tissue Massage; Other: ESWT

Study type: Interventional

Funder types: Other

Identifiers

NCT07056426

MTSS01

Details and patient eligibility

About

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.

Full description

Medial Tibial Stress Syndrome (MTSS) is often inadequately treated with standard methods. This study aimed to investigate the effects of deep tissue massage, considered as an alternative and adjunct treatment method, on pain and functional capacity in individuals diagnosed with MTSS, and to compare its efficacy with Extracorporeal Shock Wave Therapy (ESWT), a widely accepted treatment. The study was designed as a prospective, parallel-group trial and conducted at a sports health laboratory affiliated with a physical therapy and rehabilitation hospital. The study population consisted of patients who met MTSS diagnostic criteria and presented to a sports medicine outpatient clinic.

MTSS is characterized by pain along the medial border of the tibia during running or walking, with a gradual onset unrelated to traumatic events, and diffuse pain upon palpation along the medial tibial border. It is one of the most common overuse injuries affecting a significant portion of the athletic population. Although the exact pathophysiology of MTSS is not fully understood, pain is thought to originate from inflammation at the periosteal-fascial junction or enthesis area, involving only soft tissues without bone stress reactions or fractures; however, bone involvement may coexist and exacerbate pain.

Various treatment approaches have been proposed for MTSS, including rest, activity modification, exercise programs, ESWT, and injections. Limited studies exist evaluating the efficacy of radial ESWT, which have shown improved recovery and return-to-sport rates compared to control groups. Nevertheless, ESWT has been insufficient for some patients, highlighting the need for alternative treatments. While the soleus muscle is generally considered the primary contributor to MTSS, the flexor digitorum longus and deep leg fascia also play roles due to their origins on the medial tibia. Deep tissue massage has been effective in plantar heel pain but lacks sufficient evidence in MTSS patients.

The purpose of this study was to assess the effect of deep tissue massage (targeting the soleus, flexor digitorum longus, and deep leg fascia) on pain in individuals with MTSS and to compare it with ESWT. A pilot study was planned with a total of 22 participants (11 per group), based on an estimated large effect size (Cohen's d=1.30). Participants received either ESWT or deep tissue massage in addition to transcutaneous electrical nerve stimulation (TENS) and a standard exercise program. The exercise program consisted of 12 sessions of 40 minutes each, three times per week. Both ESWT and deep tissue massage were applied once weekly for four sessions. ESWT parameters included 2000 pulses per session, 2.5 bar pressure, 8 Hz frequency, and an energy flux density of approximately 200 mJ/mm². Deep tissue massage was performed with the patient lying on their side, knee flexed at 45 degrees, applying moderate pressure along the medial tibial line. Pain during massage was maintained at 7-8 on the Visual Analog Scale (VAS), with repeated 10-15 second applications.

The study duration was planned for one year following ethical approval, with recruitment starting in February 2025 and completion aimed for December 2025. Inclusion criteria were age over 18, recreational or professional athletes, diagnosed with MTSS as defined, and symptoms persisting for at least 3 weeks without any exclusion criteria. Exclusion criteria included presence of stress fractures or other fractures, history of chronic exertional compartment syndrome, previous ESWT or deep tissue massage for MTSS, rheumatologic diseases, local infection or tumor in the treatment area, pregnancy, bleeding disorders, advanced osteoarthritis of the ipsilateral knee or ankle, recent local injections, or prior knee/ankle surgery. Participants had the right to withdraw from the study at any time.

Outcome measures included demographic data collection before treatment and assessments at baseline, immediately after treatment, and at 8 weeks. Pain intensity was measured using the VAS during rest and exercise over the previous week. The painful area along the tibial border was measured in length. The Foot and Ankle Ability Measure (FAAM) assessed changes in physical function via self-reported questionnaires. Participants completed a treadmill test at a fixed speed of 10 km/h for 2000 meters, recording pain onset distance and pain levels at test completion or termination. The navicular drop test evaluated the medial longitudinal arch height difference between sitting and standing positions. The Foot Posture Index assessed foot posture across multiple segments using six criteria rated on a Likert scale.

Enrollment: 22 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

ESWT

Experimental group

Description:

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.

Treatment:

Other: ESWT

Other: Exercises

Deep Tissue

Experimental group

Description:

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.

Treatment:

Other: Deep Tissue Massage

Other: Exercises