Central Nervous System Focused Therapy in Frozen Shoulder
Condition: Frozen Shoulder
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      Frozen shoulder has been considered a self-limiting and benign disease with complete
      resolution of pain and ROM, but this can sometimes last for years. This prolonged pain and
      disability deprives patients of their routine life, occupational and recreational activities.
      Although appropriate treatment is needed so that they can quickly return to their lives,
      definitive treatment strategies have not been established and many different management
      strategies are used. The aim of this study is to investigate whether pain education and
      sensory education applied together with conventional physiotherapy are more effective than
      conventional physiotherapy alone.In this study, 21 people diagnosed with frozen shoulder who
      were referred by the doctor of Esenler Medipol Hospital, Department of Physical Therapy and
      Rehabilitation will be included in the study.

      Outcome measures: Pain Beliefs Scale, Pain Catastrophizing Scale, PainDetect Questionnaire,
      Tampa Kinesiophobia Scale, Shoulder Pain and Disability Index, Visual Analog Scale,
      Electrogoniometer, Two-point discrimination test, Numeric Rating Sleep Scale and Right/ Left
      Judgement Task.

      This study was designed as a prospective randomized controlled trial. 21 people were included
      in the study. Participants were randomly divided into two groups: Conventional physiotherapy
      group (CP group) (n=11), Conventional physiotherapy plus central nervous system focused
      treatment group (CP+CNS group) (n=10). Conventional physiotherapy was applied to both groups
      for 45-60 minutes, 5 days a week for 4 weeks.

      The CP group treatment session will take place as follows: Scapular mobilization, passive
      stretches, stick exercises, pendulum exercises and shoulder flexion, extension, internal
      rotation, external rotation, horizontal abduction/ adduction strengthening exercises.

      The CP+CNS group received central nervous system focused therapy that included chronic pain
      education, localization training, graphesthesia, graded motor imagery and mirror therapy in
      addition to conventional physiotherapy.

      The IG group protocol includes:

        1. week: Initial Evaluation, Conventional physiotherapy (CP), Chronic Pain Education,
           Localization Training Level 1, Right / Left Discrimination Training

        2. week: CP, Motor Imagery, Localization Training Level 2

        3. week: CP, Grafestesis Training, Isometric Exercise

        4. week: CP, Mirror Therapy, Functional Exercises, Final Evaluation
    

Detailed description: 
      First week:

        -  Initial Evaluation

        -  Conventional physiotherapy (CP) (5 days)

        -  Chronic Pain Education (5 days):Chronic pain education is a therapeutic treatment
           strategy that explains the patient's past experiences of pain in terms of
           neurobiological and neurophysiological rather than anatomical or biomechanical models.
           Detailed chronic pain education is needed to redefine the concept of pain and to
           convince the patient that the cause of their symptoms is hypersensitivity of the central
           nervous system rather than local tissue damage. For this reason, chronic pain education
           modules were created by the researcher to be presented to the participants in order to
           change their pain beliefs through the reconceptualization of pain. Nociceptive
           mechanisms in acute pain and chronic pain were explained comparatively at the beginning.
           A presentation supported by visuals and examples was prepared to guide during the
           chronic pain education, but a flexible schedule of 15-20 minutes was created by
           increasing the number of examples and in more detail according to the education level of
           the patient, preventing the patient from being bored during the session.

        -  Localization Therapy Level 1 (5 days): This level only the localization of the stimulus
           was trained. A grid-like sticky paper with 9 holes punched was placed over the affected
           shoulders of the participants and the training began by showing a standard photograph of
           the shoulder on which the 9-hole grid was marked. The spacing of the grids was
           determined on the basis of available data based on two-point separation of the shoulder
           joint.This data range was 43.18 mm ± 10.37 mm. The standard limits for placement of the
           9-hole grid on the shoulder are as follows: 1 cm proximal to the acromioclavicular joint
           and the lower border of the insertion of the deltoid muscle. The thick end of the probe
           and the 9-hole grill and their placement on the shoulder are introduced. After the
           familiarization period, the patient continues training with the thick end of the probe
           (2 seconds) using a random number sequence. In the first week, stimulus was applied by
           asking random numbers 4 days a week, 3 sets every day and 20 numbers in each set.

        -  Right / Left Discrimination Training (5 days): In the first week, an online computer
           program, Recognise Shoulder (Recognise Online, NOI Group, Adelaide, SA, Australia) was
           used to present participants with randomly selected photographs of their right or left
           shoulder. Shoulder photos presented in various directions. Participants were asked to
           press one of the buttons on the left and right of the screen to indicate whether the
           photograph was of the right or left shoulder. An important point here was to give the
           response corresponding to the body part as quickly as possible, and for this purpose,
           the participants were asked to respond within 5 seconds during the application. The
           training was carried out in three sets, each set consisting of 30 photographs.

      Second week:

        -  Conventional physiotherapy (CP)

        -  Motor Imagery (5 days): In our study, participants were asked to imagine they were
           moving their painful shoulders with motor imagery training. Participants were asked to
           sit in a comfortable position, close their eyes, and imagine being in an environment
           where they felt comfortable. Photographs containing 8 shoulder postures were used in the
           training. 8 photos were applied in two sets and 20 repetitions. Each photograph was
           shown live to the participants by the physiotherapist and the participant was asked to
           imagine the motion shown as painless, smooth and full range of motion. Participants were
           asked not to imagine watching themselves while imagining shoulder movements, but to
           perform the movements in the first person.

        -  Localization Training level 2 (5 days): They were asked to distinguish both the
           localization of the stimulus and the size of the probe used. The working pattern is the
           same as for localization level 1, but two types of probes are used, pointed (pencil tip)
           and coarse tip (mushroom). Three randomly applied sets of both position and probe sizes
           and a random array of 20 numbers in each set were used.

      Third week:

        -  Conventional physiotherapy

        -  Grafestesis Training (5 days): In our study, randomized capital letters were drawn
           consecutively on the affected shoulder of the participant by the physiotherapist using
           the index finger. On the second day, the randomized letters were drawn in lowercase and
           the patient was asked to say the correct letter. On the third day, the randomized
           letters drawn on the shoulder were presented in different directions and the participant
           was asked to say the correct letter. On the fourth day, random letters were presented in
           slow, fast, and normal speed and the participant was asked to say the correct letter. On
           the fifth day, 20 meaningful words consisting of three letters were formed. It was
           written overlapping the participant's shoulder and the patient was asked to say the
           meaningful word.

        -  Isometric exercise (5 days): Three sets of isometric exercises including shoulder
           flexion, extension, abduction and adduction movements, each set consisting of 7-10
           repetitions and each movement lasted for 10 seconds, were performed. The participant
           completed the movements with controlled breathing while performing the movements, and a
           1-3 minute rest break was given between each set.

      Fourth week:

        -  Conventional physiotherapy

        -  Mirror Therapy (5 day): A large mirror with wheels was placed in front of the
           participant with the unaffected arm facing the reflective side of the mirror, and the
           participant was allowed to flex the trunk to see the unaffected arm. Mirror therapy
           initially began with the unaffected arm watching its movements on the moon. It was said
           that when the participant was confident that he could do the mirror exercises
           painlessly, he could start performing the movements with the affected shoulder at the
           same time. Afterwards, progress was made towards active movements involving shoulder
           flexion, abduction, internal rotation and external rotation, including the affected arm.
           In the clinic, a training was planned for 2 sets, lasting 12-15 minutes, and rest
           periods of 1-3 minutes between each set.

        -  Functional Exercises (5 day): The movements that the participant had difficulty in daily
           life were determined during the individual interview, and exercises similar to these
           movements and specifically aimed at increasing functionality were planned in the clinic
           and applied for 15 minutes. Functional exercises wiping the wall opposite the wall at
           different degrees of flexion and abduction in close and far distances, wiping the wall
           with narrow and wide circumcision movements, picking up colored papers placed on the
           mirror at different angles and placing them at different angles, squeezing the ball
           while shoulder flexion and abduction involved rolling the ball wide and narrow with the
           shoulder at different angles.

        -  Final Evaluation
    

Intervention name(s): Intervention group (IG); Control group (CG)
Intervention type(s): Other; Other
Intervention description(s): Participants randomized to this treatment will receive a central nervous system-focused intervention consisting of a 20-session treatment program delivered in 30-45-minute sessions scheduled 5 days a week over a 4-week period and standard physical therapy will be continued.
Chronic pain training will be given according to the needs of the person and 5-10 minutes will be allocated every day for the first week and chronic pain education will be divided into modules.
Right / Left Discrimination Training
Localization Training Level 1- Level 2 Training
Visual imagination Training
Visual Imagery Training
Mirror Therapy
Isometric and functional exercises; The control group will receive only conventional physiotherapy. Conventional physiotherapy will be 5 days a week.
The conventional physiotherapy treatment session will take place as follows.
Electrotherapy
Scapular mobilization
Passive stretches
Stick Exercises
Pendulum Exercises
Shoulder flexion, extension, internal rotation, external rotation, horizontal abduction/ adduction strengthening exercises
Conventional physiotherapy intervention is planned for 45-60 minutes a day, five days a week for both groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment