Effects of Silver Spike Point Therapy on Pelvic Girdle Pain PAIN

Study Overview
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Brief Summary
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The aim of this study is to determine the effects of Silver Spike Point Therapy (SSPT) therapy on pelvic girdle pain and functional activities in pregnancy.The finding of this study will help to establish the role of SSPT therapy to relieve pelvic girdle pain in pregnant females along with exercises. SSP for pelvic girdle pain management can prove to be a useful method. The findings of this study can play a role to establish more rigorous treatment plans for pelvic girdle pain in the pregnant population in the future.

Detailed Description
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This study will be a randomized clinical trial that will investigate the effectiveness of silver spike point therapy and manual therapy in subjects with pregnancy-related pelvic girdle pain. Subjects with pregnancy-related pelvic girdle pain meeting the predetermined inclusion & exclusion criteria will be divided into two groups using the lottery method. Pre-assessment will be done using NPRS and PGPQ as subjective measurements and PSFS as objective measurements. Subjects in one group will be treated with silver spike point therapy and manual therapy, the other will be treated with manual therapy only. Each subject will receive 10 treatment sessions, with 05 treatment sessions per week. Post-treatment reading for NPRS, PGPQ, and PSFS will be recorded after the end of the 10th treatment session. Recorded values will be analyzed for any significant difference between pre and post-treatment values SPSS 21.

Official Title
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Effects of Silver Spike Point Therapy on Pelvic Girdle Pain and Functional Activities in Pregnancy

Conditions
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Pelvic Girdle Pain

Intervention / Treatment
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* Device: Silver Spike Point Therapy (SSPT)
* Other: Conservative Managment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female aged between 20 to 40 years of age Healthy pregnancy 14 to 38 weeks gestation Expecting a singleton fetus 2 out of 3 tests positive for PGP according to European guidelines for pelvic girdle pain(Posterior pelvic pain provocation (P4), Patrick's Faber, Modified Trendelenburg's test) Exclusion Criteria: High-risk pregnancy, Caudaequina Syndrome, Trauma, or spinal surgical history. Inflammatory, infective, metabolic, neoplastic, or degenerative conditions. Sensory symptoms associated with disc herniation or compressive spinal lesion. Any contraindication to exercise.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: silver spike point Therapy Group<br>One group will receive electrotherapy (silver spike point) for 10 mints along with conservative managment | Device: Silver Spike Point Therapy (SSPT)<br>* Silver Spike Point Therapy (SSPT) means passing an electric current through the skin surface with the triangle spike silver coated metal electrode. SSPT was reported by Hyoto and Kitade in Edinburg, Scotland. 3rd World Congress on Pain in 1981; It has a number of advantages over traditional narcotic medication in pelvic girdle pain management. It does not depress the cardiovascular, respiratory, or the metabolic systems and has no apparent effect on the sensorium<br>|
| Active Comparator: Conservative treatment group<br>2nd group will receive strengthening, stretching and stabilization exercises for prlvic girlde | Other: Conservative Managment<br>* 2 sets of 10 repetitions Bridging, Cat & cow exercises, Back press exercises, stretching of hip external rotators and extensors 20 sec / stretch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale (NPRS): | Pain intensity is frequently measured on an 11-point pain intensity numerical rating scale (PI- NRS), where 0=no pain and 10=worst possible pain. However, it is difficult to interpret the clinical importance of changes from baseline on this scale (such as a 1- or 2-point change) | 2 weeks | 
| Pelvic Girdle Pain Questionnaire (PGPQ): | The Pelvic Girdle Questionnaire (PGQ) is a condition-specific measure for women with pelvic girdle pain (PGP). The PGQ includes items relating to activity/participation and bodily symptoms and has reliability, validity, and feasibility for use in research and clinical practice | 2 weeks | 
| Patient specific Functional Scale (PSFS) | Patient Specific Functional Scale was developed by Stratford et al 1995 as a self-report outcome measure of function that could be used in patients with varying levels of independence. The aim of PSFS is to provide clinicians with a valid, reliable, responsive andefficient outcome measure that would be easy to use and applicable to a large number of clinical presentations. Patient- Specific Functional Scale is an efficient and valid measure for assessing disability and change in disability in persons with musculoskeletal diseases | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic girdle pain