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Completed

NCT Number: NCT05355220

Effects of Silver Spike Point Therapy on Pelvic Girdle Pain PAIN

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.

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Key information

Conditions

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

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hamza Hospital,

Lahore, Punjab Province, 54700, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Numeric Pain Rating Scale (NPRS):

    Time frame: 2 weeks

    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. Pelvic Girdle Pain Questionnaire (PGPQ):

    Time frame: 2 weeks

    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

  3. Patient specific Functional Scale (PSFS)

    Time frame: 2 weeks

    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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 2, 2022
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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