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ICMR grant proposal. 148/July 2014. Title of the project. Ultrasound and Phonophoresis on the improvement of pain and function of patients with tendenopathies of Shoulder - Randomized controlled trial. Objectives :.
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ICMR grant proposal 148/July 2014
Title of the project Ultrasound and Phonophoresis on the improvement of pain and function of patients with tendenopathies of Shoulder - Randomized controlled trial.
Objectives : • To check the effectiveness of Ultrasound on pain and function of patients with tendenopathies of Shoulder. • To check the effectiveness of Phonophoresis using Piroxicam on the improvement of pain and function of patients with tendenopathies of Shoulder. • To compare, the effectiveness of Ultrasound and Phonophoresis.
Introduction • Shoulder pain • Physiotherapy • Ultrasound • Phonophoresis • US & Phonophoresis – Published mixed results
Study Design: Randamized clinical trial Study Population: Patients diagnosed having any shoulder tendenopathies in the age group of 17-50 years of both gender. Total number of samples: Will be calculated after pilot study.
Exclusion Criteria: • Any deformities limiting the range of motion and functional activities. • Recent trauma including dislocations, fractures and soft tissue injuries. • Patients with any associated problems like cervical radiculopathy. • Any pain arises from neural or visceral origin. • Patients with metabolic disorders • Allergic to Piroxicam • Hydrophobias • Patient undergone local steroid injection within past 6 months
Mode of selection of samples: • Patients diagnosed by Orthopaedicians having shoulder pain and functional disability due to any shoulder tendenopathies for not less than1 week will be included for the study. • Informed consent • Through clinical examination • Questionnaire and • special tests for soft tissue integrity, Eligible participants will be randomly assigned to any of the 3 groups.
Group I: Piroxicam Phonophoresis in an appropriate position according to the involvement of the tendon. • Dosage: Continuous Ultrasound with the intensity of 1.5 w/cm2 for 7 minutes. Group II :Participants will receive pulsed or continuous Ultrasound according to the stage of the conditions and as prescribed(www.electrotherapy.org/)
Group III: Participants will receive Cryotherapy (20 minutes) and deep friction massage (5-10 minutes) Exercises: Designated exercises according to the involvement of the tendons will be taught to the participants and will be asked to repeat the exercises 3 times a day. Exercises will be taught to all the three groups. • Sessions: Participant will be treated on alternate days for 10 days in all the groups.
Blinding: • To avoid bias blinding will be followed. • A qualified senior physiotherapist will do assessment and follow up. • Participants will be allotted by random allocation by a sealed envelope. • Researcher will administer only the therapy according to the group they are assigned. • Coupling media will be coded and maintained by the pharmacologist to blind the Piroxicam gel from the researcher.
Preparation of gel: • Adequate amount of aqua sonic gel will be given to the pharmacology department t • 50% of the gel will be mixed with 0.5% Piroxicam and remaining 50% will be only opened and sealed by the pharmacologist. • Preparation of Piroxicam gel: Raw Piroxicam chemical will be purchased. • Before sending to the researcher, the department will have a trial on animal model for its effects and to avoid any complications. • All the containers will be coded and maintained by the preparing Pharmacologist. • Code will be asked only at the end of study for analysis. This will allow the researcher to be blinded from the type of gel used for treatment.
Ethical issues: • Required ethical clearance and related institutional formalities will be followed. • Permission required for using animal for testing the prepared Piroxicam gel. • Certification from the department to use the formulated gel.
Data collection: • Baseline data on the first day of treatment will be documented. The senior therapist will measure Pre and post session effects on every visit. • Data analysis: For statistical analysis 1st 3rd 6th 9th and 10th days pre and post scores will be compared with baseline data. Analysis will be done within the group and between the groups. SPSS will be used for analysis. • Proposed Statistical plan: One way ANOVA for comparing the three groups. Student paired ‘t’ for comparing pre and post scores within the groups. Wilcoxan signed rank test for ranking the participants satisfaction on the treatment.
Outcome measures: Pain, functional ability and satisfaction of the received treatment will be considered for analysis. • Intensity of Pain perceived by the participants will be assed using 10 cm Visual Analog Scale (VAS) • DASH (Disability of Arm Shoulder and Hand) will be used for functional status. • Penn shoulder score especially for shoulder functions. • A Likert scale to assess the self-satisfaction of the participants. • All the questionnaire will be translated into Kannada and Malayalam by an language expert and the reliability will be checked by retranslation into English.
Termination from the study: • Participants will be terminated from the study if there is aggravation of symptoms or not willing to continue the treatment.
