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Effects of Silver Spike Point Therapy on Pelvic Girdle Pain PAIN

Primary Purpose

Pelvic Girdle Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Silver Spike Point Therapy (SSPT)
Conservative Managment
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Girdle Pain focused on measuring Pelvic girdle pain

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hamza Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

silver spike point Therapy Group

Conservative treatment group

Arm Description

One group will receive electrotherapy (silver spike point) for 10 mints along with conservative managment

2nd group will receive strengthening, stretching and stabilization exercises for prlvic girlde

Outcomes

Primary Outcome Measures

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)
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
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

Secondary Outcome Measures

Full Information

First Posted
April 21, 2022
Last Updated
November 8, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05355220
Brief Title
Effects of Silver Spike Point Therapy on Pelvic Girdle Pain PAIN
Official Title
Effects of Silver Spike Point Therapy on Pelvic Girdle Pain and Functional Activities in Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
October 10, 2022 (Actual)
Study Completion Date
October 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Girdle Pain
Keywords
Pelvic girdle pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
silver spike point Therapy Group
Arm Type
Experimental
Arm Description
One group will receive electrotherapy (silver spike point) for 10 mints along with conservative managment
Arm Title
Conservative treatment group
Arm Type
Active Comparator
Arm Description
2nd group will receive strengthening, stretching and stabilization exercises for prlvic girlde
Intervention Type
Device
Intervention Name(s)
Silver Spike Point Therapy (SSPT)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Conservative Managment
Intervention Description
2 sets of 10 repetitions Bridging, Cat & cow exercises, Back press exercises, stretching of hip external rotators and extensors 20 sec / stretch
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS):
Description
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)
Time Frame
2 weeks
Title
Pelvic Girdle Pain Questionnaire (PGPQ):
Description
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
Time Frame
2 weeks
Title
Patient specific Functional Scale (PSFS)
Description
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
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghulam Fatima, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamza Hospital,
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54700
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Abdul Salam K. A Comparative study to Assess the Effectiveness of Combined Tens andExercises over Exercise Alone for Sacroiliac Joint Pain in Pregnancy: College of Physiotherapy,Trinity Mission and Medical Foundation, Madurai; 2011.
Results Reference
background
PubMed Identifier
26271756
Citation
Casagrande D, Gugala Z, Clark SM, Lindsey RW. Low Back Pain and Pelvic Girdle Pain in Pregnancy. J Am Acad Orthop Surg. 2015 Sep;23(9):539-49. doi: 10.5435/JAAOS-D-14-00248. Epub 2015 Aug 13.
Results Reference
background
PubMed Identifier
18259783
Citation
Vleeming A, Albert HB, Ostgaard HC, Sturesson B, Stuge B. European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008 Jun;17(6):794-819. doi: 10.1007/s00586-008-0602-4. Epub 2008 Feb 8.
Results Reference
background
PubMed Identifier
18582370
Citation
Elden H, Ostgaard HC, Fagevik-Olsen M, Ladfors L, Hagberg H. Treatments of pelvic girdle pain in pregnant women: adverse effects of standard treatment, acupuncture and stabilising exercises on the pregnancy, mother, delivery and the fetus/neonate. BMC Complement Altern Med. 2008 Jun 26;8:34. doi: 10.1186/1472-6882-8-34.
Results Reference
background
PubMed Identifier
15094530
Citation
Stuge B, Laerum E, Kirkesola G, Vollestad N. The efficacy of a treatment program focusing on specific stabilizing exercises for pelvic girdle pain after pregnancy: a randomized controlled trial. Spine (Phila Pa 1976). 2004 Feb 15;29(4):351-9. doi: 10.1097/01.brs.0000090827.16926.1d.
Results Reference
background
Citation
Lee KS, Kim YH, Min KH, Yoo HK, Hwang YH, Chung CK, et al. Clinical Study of thePostperative Pain Management with Silver Spike Point Electro-therapy. Korean Journal of Anesthesiology. 1985;18(1):63-70.
Results Reference
background
PubMed Identifier
32903997
Citation
Sawada T, Tateyama N, Ikeda T, Ishimaru K. The Effect on Muscle Hardness of Acupuncture Stimulation Using Low-reactive Level Laser Therapy and Silver Spike Point Therapy, along with Stretching. Laser Ther. 2020 Jul 17;29(1):41-46. doi: 10.5978/islsm.20-OR-04.
Results Reference
background
Citation
Yi D-H, Kim B-R, Hur Y-J, Kim D-H, Shim S-Y, Yim J-E. Convergence of Acupoint andElectrical Stimulation Therapy for Blood Flow and Pain Threshold. Journal of the Korea Convergence Society. 2019;10(6):79-87.
Results Reference
background
PubMed Identifier
18604250
Citation
Taguchi R. Acupuncture anesthesia and analgesia for clinical acute pain in Japan. Evid Based Complement Alternat Med. 2008 Jun;5(2):153-8. doi: 10.1093/ecam/nem056.
Results Reference
background
Citation
Xu H, Ryan J, Li K. Clinical Investigation into the effectiveness of needleless acupuncture inthe management of the symptoms of osteoarthritis of the knee: a preliminary, single-blind and sham- controlled study. Australian Journal of Acupuncture and Chinese Medicine. 2007;2(2):9-15.
Results Reference
background
PubMed Identifier
8628583
Citation
Ishimaru K, Kawakita K, Sakita M. Analgesic effects induced by TENS and electroacupuncture with different types of stimulating electrodes on deep tissues in human subjects. Pain. 1995 Nov;63(2):181-187. doi: 10.1016/0304-3959(95)00030-V.
Results Reference
background

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Effects of Silver Spike Point Therapy on Pelvic Girdle Pain PAIN

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