Comparison of Soft Tissue Biased Manual Therapy and Conventional Physical Therapy in Patients With Frozen Shoulder
Condition: Frozen Shoulder; Shoulder Adhesive Capsulitis
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      Adhesive capsulitis, also known as frozen shoulder (FS), is a condition characterized by the
      functional restriction of both active and passive shoulder motion with unremarkable
      glenohumeral joint radiographs findings. Shoulder pain almost exists during the whole course
      of frozen shoulder. Pain induces muscle spasm and causes pain-spasm-pain cycle resulting in
      limited range of motion, changed muscle recruitment pattern and finally influences
      neuromuscular control. Commonly used conservative interventions for FS patients include joint
      mobilization, corticosteroid injection, exercise, modality and soft tissue mobilization.
      Despite joint mobilization is the most commonly used manual therapy in patients with FS, the
      evidence level is weak and the efficacy is not superior to other conservative treatments.
      Soft tissue mobilization is widely used in lots of musculoskeletal conditions. The effects of
      soft tissue mobilization include breaking the adhesion tissue and improving range of motion,
      muscle strength and motor control. However, few studies have investigated the effect of soft
      tissue mobilization in patients with frozen shoulder. Therefore, the purpose of this study is
      to investigate and compare the effect of soft tissue biased manual therapy and conventional
      physical therapy in patients with primary FS.
    

Detailed description: 
      Adhesive capsulitis, also known as frozen shoulder (FS), is a condition characterized by a
      functional restriction of both active and passive shoulder motion with unremarkable
      glenohumeral joint radiographs findings. Frozen shoulder is divided into primary and
      secondary type. The mechanism of primary FS is still unknown and the secondary FS may
      accompany with shoulder injuries. The incidence of primary FS is 2 to 5.8% and the risk
      factors are diabetes and thyroid disease.

      The course of FS is divided into four consecutive stages which are inflammation, painful,
      frozen and thawing phase. Shoulder pain almost exists during the whole course of frozen
      shoulder. The pain and discomfort of FS patients are frequently localized to the deltoid
      insertion and coracoid process. Pain induces muscle spasm and causes pain-spasm-pain cycle
      resulting in limited range of motion, changed muscle recruitment pattern and finally
      influences neuromuscular control.

      Commonly used conservative interventions for FS patients include joint mobilization,
      corticosteroid injection, exercise, modality and soft tissue mobilization. Despite joint
      mobilization is the most commonly used manual therapy in patients with FS, the evidence level
      is weak and the efficacy is not superior to other conservative treatment s. Soft tissue
      mobilization is widely used in lots of musculoskeletal conditions. The effects of soft tissue
      mobilization include breaking the adhesion tissue and improving range of motion, muscle
      strength and motor control. However, few studies have investigated the effect of soft tissue
      mobilization in patients with frozen shoulder. Only one study used one-time muscle release to
      FS patients and investigate improvement in shoulder biomechanics, muscle strength and ROM.
      Therefore, the purpose of this study is to investigate and compare the effect of soft tissue
      biased manual therapy and conventional physical therapy for six weeks in patients with
      primary FS.

      The study design is a pretest-posttest control group design. The investigators plan to
      recruit 70 patients with primary frozen shoulder and divide them into a soft tissue biased
      manual therapy group and a conventional physical therapy group. The sample size is determined
      by the previous study. It is based on a significance level of 0.05, and a power of 0.80. The
      outcome measures in this study include scapula kinematics, scapula position, the range of
      motion, muscle tone, muscle strength, pain and functional impairment.

      LIBERTY™ electromagnetic tracking system (Polhemus, Colchester, VT, USA) was used to collect
      three-dimensional kinematic (3D) data during scaption, hand to neck and hand to back tasks at
      a sampling rate of 120 Hz, and the software Motion Monitor® (Innovative Sport Training, Inc.,
      Chicago. IL. USA) was used to analyze the data. The main measurements of shoulder kinematics
      include scapular upward/downward rotation, internal/external rotation, and anterior/posterior
      tilt. A stylus was used to digitize the bony landmarks for defining the anatomical coordinate
      system. The methods for this measure have been described previously.

      For collecting muscle activation data, the investigators used surface electromyography (sEMG,
      TeleMyo 2400 G2 Telemetry; Noraxon USA, Inc., USA) to collect scapular muscles' activation
      during those tasks. The investigators will measure the muscle activities of the pectoralis
      major, upper trapezius, infraspinatus, teres major and lower trapezius. The electrodes will
      be placed according to previous studies and be positioned in parallel to the direction of the
      muscle ﬁbers.

      The range of motion of shoulder flexion, abduction, external rotation and internal rotation
      will be measured by plastic universal goniometer according to Norkin's methods. The muscle
      strength of lower trapezius, external rotators and internal rotators are measured by the
      hand-held dynamometer. The scapula positions are measured by modified scapular sliding test
      with calliper during arms by sides, hands on the hips and scaption 90 degrees. The muscle
      tone of pectoralis major, upper trapezius, infraspinatus and teres complex will be measured
      by hand-held myotonometer (Myoton-Pro, Myoton AS, Tallinn, Estonia) in shoulder resting
      position according to previous studies. The functional impairments are measured by Flexilevel
      Scale of Shoulder Function questionnaire. The pain level is measured by the visual analogue
      scale.

      Participants in the soft tissue biased manual therapy group will receive heat and muscle
      release for six weeks and participants in conventional physical therapy group will receive
      modalities and joint mobilization for six weeks. The measurement will be obtained at
      baseline, 3 weeks, and after the intervention. Repeated measures ANOVA will be used for data
      analysis. The level of significance sets at α=0.05.
    

Intervention name(s): Soft tissue biased manual therapy group; Conventional physical therapy group
Intervention type(s): Other; Other
Intervention description(s): It includes hot pack and muscle release technique of pectoralis major, pectoralis minor, teres major, teres minor, infraspinatus and posterior deltoid muscles. Subjects are supine on the bed. The muscle release technique is applied at the end available range and the acceptable intensity. The time of muscle release intervention is about 30 min and hot-pack about 15 min.; It includes modality (electrotherapy, ultrasound and low-level laser therapy) and GH joint mobilization. GH joint mobilization includes anterior to posterior glide, caudal glide and distraction. The intensity of joint mobilization is grade III to IV. The time of joint mobilization is about 30 min and hot-pack for 15 min.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects are divided into soft tissue biased manual therapy group and conventional physical therapy group by two different hospitals
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Frozen Shoulder; Manual therapy; Soft tissue mobilization