Effects of Silver Spike Point Therapy on Pelvic Girdle Pain PAIN

NCT05355220 | Completed

• 1 other identifier: REC/Lhr/22/0506 Maida
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Girdle Pain

Keywords

Pelvic girdle pain

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

silver spike point Therapy Group

EXPERIMENTAL

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

Device: Silver Spike Point Therapy (SSPT)

Conservative treatment group

ACTIVE COMPARATOR

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

Other: Conservative Managment

Interventions

Silver Spike Point Therapy (SSPT) DEVICE

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

silver spike point Therapy Group

Conservative Managment OTHER

2 sets of 10 repetitions Bridging, Cat \& cow exercises, Back press exercises, stretching of hip external rotators and extensors 20 sec / stretch

Conservative treatment group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female aged between 20 to 40 years of age
• Healthy pregnancy
• to 38 weeks gestation
• Expecting a singleton fetus
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Hamza Hospital,

Lahore, Punjab Province, 54700, Pakistan

Location

Related Publications (11)

• 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.

  BACKGROUND

• 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.

  PMID: 26271756 BACKGROUND

• 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.

  PMID: 18259783 BACKGROUND

• 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.

  PMID: 18582370 BACKGROUND

• 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.

  PMID: 15094530 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 32903997 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 18604250 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 8628583 BACKGROUND

MeSH Terms

Conditions

Pelvic Girdle Pain

Condition Hierarchy (Ancestors)

Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Study Officials

• Ghulam Fatima, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 2, 2022
• Study Start: April 1, 2022
• Primary Completion: October 10, 2022
• Study Completion: October 25, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)