1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [drpankajjayswal@gmail.com].
   


6. For how long will this data be available start date provided 02-06-2026 and end date provided 02-06-2031?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NO

Introduction :

•       Frozen shoulder, is also known as adhesive capsulitis  ,an insidious painful condition of the shoulder persisting more than 3 months. This inflammatory condition that causes fibrosis of the glenohumeral joint capsule is accompanied by gradually progressive stiffness and significant restriction of range of motion (typically external rotation). The patients may develop symptoms suddenly and have a slow recovery phase. The recovery is satisfying in most of the cases, even though this may take up to 2 to 3 years.

Stages :

“Freezing” Characterized by intense pain even at rest and limitation of motion by 2 to 3 weeks after onset. These acute symptoms may last 10 to 36 weeks.

•       “Frozen.” Characterized by pain only with movement, adhesions, and limited GH motions, with substitute motions in the scapula. Atrophy of the deltoid, rotator cuff, biceps, and triceps brachii muscles occurs. This stage lasts 6to 12 months.

•       “Thawing.” Characterized by no pain and no synovitis but significant capsular restrictions from adhesions. This stage lasts 6 to 24 months or longer. Some patients never regain normal ROM

•       Frozen shoulder is usually described as fibrotic, inflammatory contracture of the rotator interval, capsule, and ligaments. However, the development of frozen shoulder  remains not fully understood. Although disagreements exist,  the most recognized pathology is cytokine-mediated synovial inflammation with fibroblastic proliferation based on arthroscopic observations. Additional findings include adhesions around the rotator interval caused by increased collagen and nodular band formation.In advanced stages, thickening and contraction of the glenohumeral joint capsule develop, further limiting the range of motion in all directions.

•       Innervation of the shoulder joint is provided by the Suprascapular nerve , Axillary Nerve, Lateral Pectoral Nerve, and Lower Subscapular nerve   which is in accordance with the Hilton’s law. The Suprascapular was found to be the greatest contributor to overall shoulder innervation. It was found to provide sensory innervation to the posterior Glenohumeral  capsule, Subacromial bursa, Coracoacromial  and acromioclavicular ligaments. Axillary nerve  was also found to innervate smaller areas involving the inferior portion of the anterior and posterior GH capsule.  The Lateral pectoral nerve also innervated the anterosuperior quadrant of the shoulder including the anterior edge of the Subacromial  bursa, the Coracoacromial  ligaments, and the Glenohumeral  capsule

•       Axillary nerve : C5 –C6

•       Suprascapular nerve :C5 –C6

•       Lateral pectoral nerve :C5 –C7

•       Lower subscapular nerve:C5-C6

•       Transcutaneous electrical nerve stimulation (TENS) is a non-invasive, inexpensive, self-administered technique to relieve pain. The purpose of conventional TENS is to selectively activate large diameter non-noxious afferents (A-beta) to reduce nociceptor cell activity and sensitization at a segmental level in the central nervous system.  Clinical experience suggests that TENS may be beneficial as an adjunct to pharmacotherapy for acute pain although systematic reviews are conflicting. Clinical experience and systematic reviews suggest that TENS is beneficial for chronic pain.

•       For pain relief  TENS can be applied at the affected area or at the nerve root level supplying that particular area and also nerve application can be done.

•       Phonophoresis is defined as the migration of drug molecules ,contained in coupling agent, through the skin under the influence of ultrasound.It causes delivery of drugs at deep level compare to the normal application or other modalities.Therefore drug would be more effective and can reach the desired destination Drugs like local anesthetics , anti inflammatory  etc. can be applied through phonophoresis

•       Mobilization :They are passive, skilled manual therapy techniques applied to joints and related soft tissues at varying speeds and amplitudes using physiological or accessory motions for therapeutic purposes.The varying speeds and amplitudes could range from a small-amplitude force applied at high velocity to a large-amplitude force applied at slow velocity; that is, there is a continuum of intensities and speeds at which the technique could be applied.

Need of study :

•       Frozen shoulder is amongst the most common ailments to be treated in physiotherapy departments with Pain being the main problem in acute phase. However intermittent pain sometimes make it difficult to give mobilization in the chronic phase.Regular mobilization may lead to severe pain and thus create negative psychological impacts resulting in some patients discontinuing their physiotherapy which may lead to severe functional disability in later stages.

•       Application of drugs like lignocaine through phonophoresis may reduce the pain and make mobilisation less painful.Application of TENS  can help in blocking the pain pathway thus making mobilisation more bearable for the patient and thus could make the procedure more efficient and decrease the total treatment span due to early functional independency. Both Phonophoresis and TENS have been used in past in different shoulder painful conditions.Therefore, it seems feasible for indulgence of those pain blocking procedure for treating chronic  frozen shoulder .

Title :          

 Effect of Phonophoresis and Mobilization with TENS at nerve root level on pain &                                 function in chronic Frozen shoulder : A Randomized control Trial

Aims & Objectives:

•       To investigate whether  phonophoresis  and Mobilization with TENS application at nerve root level could  have  beneficial impacts  on pain ,ROM & functional impairment in chronic frozen shoulder patient.

•       To find out the specific effect of lignocaine given via phonophoresis on pain, ROM & functional impairment in chronic frozen shoulder

•       To find out the effect of mobilization with TENS (simultaneous application) on pain ,ROM &  functional impairments in chronic frozen shoulder

Hypothesis

I There is effect of lignocaine phonophoresis & Mobilization with TENS at nerve root level on pain & function  in chronic frozen shoulder patients.

ii There is no additional  effect of lignocaine phonophoresis & Mobilization with TENS at nerve root level on pain & function  in chronic frozen shoulder patients.

Study population :

Frozen shoulder patients coming to Orthopaedics physiotherapy department of Dr. APJ Abdul Kalam College of physiotherapy & other clinical OPDs.

Inclusion criteria

•       Age group – 40 to 60 years

•       Positive capsular pattern (restriction of Range of motion External rotation >Abduction >Internal rotation )

Exclusion criteria

•       Secondary frozen shoulder

•       Acute stage of frozen shoulder

•       Any fracture or injury around the shoulder

Methodology :

•       First of all, sample size will be decided. Samples would be selected according to criteria. There would be total three groups in which study would be carried out.

•       First group will be given conventional physiotherapy treatment including  physical modalities and Exercises, with Maitland mobilization in end .Second group will be given conventional physiotherapy treatment and phonophoresis with the lignocaine at nerve root level  just before the  Maitland  mobilization. Third group will receive conventional physiotherapy treatment  and will also be given TENS simultaneously  at nerve root level with Maitland mobilization.

•       Pain, shoulder range of motion & functional Outcome measures will be  taken at baseline.The outcome  measures would be measured on weekly basis  for 4 weeks.

Outcome measure

•       Pain will be measured with VAS.ROM will be measured by using Universal Goniometer. Functional impairments will be calculated by using Upper extremity functional scale

References :

1.Tae-Youl Kim , Dae-In Jung, Young-Il Kim, Jae-Heon Yang, Sang-Chul Shin “Anesthetic effects of lidocaine hydrochloride gel using low frequency ultrasound of 0.5 MHz” 10(1):1-8, 2007J Pharm Pharmaceut Sci (www.cspscanada.org) 10(1):1-8, 2007

2-Barbara Cagnie, Elke Vinck, Steven Rimbaut, Guy Vanderstraeten  â€œPhonophoresis Versus Topical Application of Ketoprofen:Comparison Between Tissue and Plasma Levels” Physical Therapy . Volume 83 . Number 8 . August 2003

3-  Kathleen A. Sluka and Deirdre Walsh “Transcutaneous Electrical Nerve Stimulation: Basic Science Mechanisms and Clinical Effectiveness” The Journal of Pain, Vol 4, No 3 (April), 2003: pp 109-121