Clinical trial NCT05355220: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Girdle Pain
Keywords: Pelvic girdle pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 26
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS):
timeFrame: 2 weeks
measure: Pelvic Girdle Pain Questionnaire (PGPQ):
timeFrame: 2 weeks
measure: Patient specific Functional Scale (PSFS)
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Hamza Hospital,
state: Punjab
Study officials:
affiliation: Riphah International University
name: Ghulam Fatima, PhD*
role: PRINCIPAL_INVESTIGATOR
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