Effect of Low Level Laser Therapy and Pelvic Stabilisation Exercises on Postpartum Pelvic Girdle Pain

NCT03606720 | Unknown DMC

• 1 other identifier: 01114933504
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

This study will be conducted to show the effect of low level laser therapy 810 nm and pelvic stabilization exercises has Effect on pelvic girdle pain Postpartum Pelvic girdle pain (PPGP) is common complaint in pregnant women all over the world and it has a major impact on health and functioning as it decreases quality of life. PGP generally arises in relation with pregnancy, trauma and reactive arthritis. The onset of PGP is usually by weeks 17-19 of gestation, with a peak of incidence by weeks 24- 36. Postpartum follow-up studies have shown that 5- 27% of the women had persisting pain 1-3 months after delivery. However, it was report that 7% have remaining pain 6 years after delivery causing severe discomfort and reduced ability to work , ninety prime-gravid or multigravida postnatal women's were randomly classified into three groups, Group (A): composed of 30 patients who received low-level laser therapy and pelvic stabilization exercises for 12 sessions over six week's period by 2 sessions per week. Group (B): composed of 30 patients who low-level laser therapy only for 12 sessions over six week's period by 2 sessions per week and Group (C): composed of 30 patients who received pelvic stabilization exercises For 12 sessions over six week's period by 2 sessions per week. Pain Using Visual analogue scale, serum cortisol level, and disability using pelvic girdle questionnaire) were measured and compared at 0 and 6 weeks after the treatment in the 3 groups.

Conditions

Pelvic Girdle Pain

Keywords

Pelvic Girdle Pain; low level laser therapy; pelvic stabilization exercises; postpartum pain

Outcome Measures

Primary Outcomes (3)

• Pain intensity:

  Pain will assessed by using VAS that is a 10 mm calibrated line with zero representing no pain and10 representing worst pain using Visual analogue scale"VAS" that is a 10 mm calibrated line with zero representing no pain and 10 representing worst pain.Worst during the past week Change from baseline to follow-up

  Baseline to 6 weeks after treatment .

• Pelvic Girdle Questionnaire

  The Pelvic Girdle Questionnaire (PG Q) is a condition-specific measure for women with pelvic girdle pain (PGP). The questionnaire has 25 items under two sub-scales (20 items for activates and 5 items for symptoms), with percentage scores that range from 0 (no disability) to 100 (great disability),thus supplying a gap in research and clinical practice. The PG Q includes items relating to activity/participation and bodily symptoms and has reliability, validity, and feasibility for use in research and clinical practice.

  Baseline to 6 weeks after treatment

• Serum cortisol level:

  Cortisol is a hormone secreted by the adrenal gland. It is the major corticosteroids. It is responsible for about 95% of all glucocorticoids activity in the body.(Pool and Axford 2001) It released into our body when we are under stress. Cortisol is high in subjects suffering from pain as compared with healthy and pain free subjects, as there is positive correction between the intensity of pain and increased plasma cortisol level. The blood sample will take for the measurement of plasma cortisol from 9 a.m. to 1 p.m. Each patient will be drawn two 5 ml blood samples from cubital vein two time

  Baseline to 6 weeks after treatment

Secondary Outcomes (2)

• FABER Test (Patrick's test)

  Baseline to 6 weeks after treatment

• Posterior pelvic pain provocation test (PPPPT)

  Baseline to 6 weeks after treatment .

Study Arms (3)

group(A) low level laser therapy

EXPERIMENTAL

composed of 30 patients who received pelvic stabilization exercises and low level laser therapy For 12 sessions over six week's period by 2 sessions per week.

Other: low level laser therapy; Other: pelvic stabilization exercises

group(B) pelvic stabilization exercises only

ACTIVE COMPARATOR

composed of 30 patients who pelvic stabilization exercises only For 12 sessions over six week's period by 2 sessions per week.

Other: pelvic stabilization exercises

group (C) low level laser therapy only

ACTIVE COMPARATOR

composed of 30 patients who low level laser therapy only For 12 sessions over six week's period by 2 sessions per week.

Other: low level laser therapy

Interventions

low level laser therapy OTHER

low level laser therapy (LLLT) is a modality that has been used by the medical profession for decades to treat acute and chronic pain conditions ranging from tendonitis and bursitis, to back pain and pelvic girdle pain.

Also known as: (LLLT)

group (C) low level laser therapy only; group(A) low level laser therapy

pelvic stabilization exercises OTHER

special program of pelvic stabilization exercises depending on exercising of transverse abdominal in addition to co activation of lumbar multifidus muscles at the lumbosacral area , exercising of oblique abdominal, gluteus maximus, latissimus dorsi muscles , quadratus lumborum, erector spinae, also, hip abductors and adductors. will done by all patients

Also known as: (PSE)

group(A) low level laser therapy; group(B) pelvic stabilization exercises only

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Female participants at least 18 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ongoing sacral pain with onset during the preceding pregnancy reported on a present pain drawing
• Pain intensity ≥4 cm as worst during the past week on a 10 cm visual analogue scale (VAS)
• One positive pain provocation test of either Posterior Pelvic Pain Provocation test, Patrick's Faber test.
• Provoked pain by a gentle pressure on the ischial spine, ipsilateral to reported sacral pain, at least unilaterally.

You may not qualify if:

• Nerve root affection in the lumbo-sacral spine
• Inflammatory disease with pelvic bone and/or spinal manifestation
• Known endometriosis, gynecologic cancer or ongoing malign disease.
• Previous surgery of the lumbar spine.
• Incapacity to complete the questionnaires.
• Age \<18 years.
• Body mass index ≥35 kg/m2.
• Intolerance to the treatment dose or negative reactions of the laser treatment.
• A new pregnancy, during treatment or between the follow-ups. -

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Cairo university

Giza, Cairo Governorate, +02, Egypt

Location

Cairo university

Giza, +02, Egypt

Location

MeSH Terms

Conditions

Pelvic Girdle Pain

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Adly A Sabbour, professor

  Cairo University

  STUDY DIRECTOR

• Mona I Morsy, professor

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: If low level laser therapy 810nm and pelvic stabilization exercises can reduce pain and improve function there will be a new treatment option for this condition
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Physical Therapist department in Imbaba general hospital

Model Details: The study were to determine whether the combination of low level laser therapy and pelvic stabilization exercises is more efficient, and possibly effective, treatment protocol in the treatment of pelvic girdle pain,and study and compare the effectiveness of specific stabilizing exercises with low level laser therapy in PGP subjects in terms of pain intensity, functional status and health-related quality of life following delivery

Study Record Dates

• First Submitted: July 14, 2018
• First Posted: July 31, 2018
• Study Start: May 1, 2018
• Primary Completion: July 1, 2021
• Study Completion: August 1, 2021
• Last Updated: December 10, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: started on October 2018
• Access Criteria: Purpose: Postpartum Pelvic girdle pain (PPGP) is common complaint in pregnant women all over the world and it has a major impact on health and functioning as it decreases quality of life. PGP generally arises in relation with pregnancy, trauma and reactive arthritis. The onset of PGP is usually by weeks 17-19 of gestation, with a peak of incidence by weeks 24- 36. Postpartum follow-up studies have shown that 5- 27% of the women had persisting pain 1-3 months after delivery. However, it was report that 7% have remaining pain 6 years after delivery causing severe discomfort and reduced ability to work

Locations

EG (2)