Low Level Laser Therapy in Persistent Pelvic Girdle Pain

NCT02789735 | Unknown

• 1 other identifier: LLLT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Persistent pregnancy-related pelvic girdle pain is common, 2-5% av all women given birth is suffering from disabling daily pain with high impact on quality of life. A prospective double-blinded randomised controlled trial will be performed with a baseline assessment 7-10 months after childbirth with follow-up directly and 6 months after a treatment period with low level laser therapy (LLLT) or sham laser treatment, given at 12 planned treatment sessions during four weeks. 60 women will be included in the study. If LLLT can reduce pain and improve function there will be a new treatment option for this condition.

Conditions

Pelvic Girdle Pain

Keywords

Pregnancy; laser therapy; persistent pain; pelvic pain

Outcome Measures

Primary Outcomes (4)

• Pain intensity (100 mm VAS) Worst during the past week

  Change from baseline to follow-up

  Baseline to 6 months after treatment

• P4-test Pressure (1, 5, 10 or 15kg) added to provoke sacral pain

  Change from baseline to follow-up

  Baseline to 6 months after treatment

• 6 minute walk test, 6MWT, distance (m)

  Change from baseline to follow-up

  Baseline to 6 months after treatment

• Disability rating index, DRI. Function past week %

  Change from baseline to follow-up

  Baseline to 6 months after treatment

Secondary Outcomes (5)

• Pain score (0-26) of provoked pain on intra-pelvic anatomical landmarks

  Baseline to 6 months after treatment

• SF-36, questionnaire

  Baseline to 6 months after treatment

• Pelvic Girdle Questionnaire, PGQ, function %

  Baseline to 6 months after treatment

• Timed Up and Go Test,TUGT, time (s)

  Baseline to 6 months after treatment

• Isometric muscle tests, isometric endurance (s)

  Baseline to 6 months after treatment

Study Arms (2)

Device: LiteCure LCT-1000®

ACTIVE COMPARATOR

Treatment with 10 J/cm²

Device: Active laser therapy

Device: Sham LiteCure

SHAM COMPARATOR

Sham i.e. visible red light

Device: Sham laser therapy

Interventions

Active laser therapy DEVICE

Laser therapy at predetermined sites

Also known as: Low level laser therapy

Device: LiteCure LCT-1000®

Sham laser therapy DEVICE

Sham therapy at predetermined sites

Device: Sham LiteCure

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ongoing sacral pain with onset during the preceding pregnancy reported on a present pain drawing
• Pain intensity ≥40 mm as worst during the past week on a 100 mm visual analogue scale (VAS)
• One positive pain provocation test of either Posterior Pelvic Pain Provocation (P4) test, Menell's test or Patrick's faber test
• Provoked pain by a gentle pressure on the ischial spine, ipsilaterally to reported sacral pain, at least unilaterally

You may not qualify if:

• A positive urinary human Chorionic Gonadotropin (hCG) test
• Nerve root affection in the lumbo-sacral spine
• Inflammatory disease with pelvic bone and/or spinal manifestation
• Known endometriosis, gynaecologic cancer or ongoing malign disease
• Previous surgery of the lumbar spine
• Corticosteroid treatment during the past 6 months and during treatment
• 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

• Uppsala University: lead

Study Sites (1)

Sundsvall Hospital

Sundsvall, SE-85651, Sweden

RECRUITING

MeSH Terms

Conditions

Pelvic Girdle Pain; Pelvic Pain

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Per Kristiansson, AssProf, PhD

  Uppsala University

  STUDY DIRECTOR

Central Study Contacts

Thomas Torstensson, PhD

CONTACT

+46706248905; thomas.torstensson@pubcare.uu.se

Per Kristiansson, AssProf, PhD

CONTACT

+46184716308; per.kristiansson@pubcare.uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: June 3, 2016
• Study Start: March 1, 2016
• Primary Completion: February 1, 2021
• Study Completion: April 1, 2021
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)