Effects of Silver Spike Point Therapy on Pelvic Girdle Pain PAIN

NCT ID: NCT05355220

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-10-25

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.

Conditions

Pelvic Girdle Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

silver spike point Therapy Group

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

Group Type: EXPERIMENTAL

Silver Spike Point Therapy (SSPT)

Intervention Type: 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

Conservative treatment group

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

Group Type: ACTIVE_COMPARATOR

Conservative Managment

Intervention Type: OTHER

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

Interventions

Silver Spike Point Therapy (SSPT)

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: DEVICE

Conservative Managment

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ghulam Fatima, PhD*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Hamza Hospital,

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 26271756 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18259783 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18582370 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15094530 (View on PubMed)

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 32903997 (View on PubMed)

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 18604250 (View on PubMed)

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 8628583 (View on PubMed)

Other Identifiers

REC/Lhr/22/0506 Maida

Identifier Type: -

Identifier Source: org_study_id