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Low Level Laser Therapy in Persistent Pelvic Girdle Pain

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ClinicalTrials.gov Identifier: NCT02789735
Recruitment Status : Recruiting
First Posted : June 3, 2016
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Uppsala University

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.


Condition or disease Intervention/treatment Phase
Pelvic Girdle Pain Device: Active laser therapy Device: Sham laser therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Low Level Laser Therapy in Persistent Pregnancy-related Pelvic Girdle Pain After Childbirth
Study Start Date : March 2016
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
Active Comparator: Device: LiteCure LCT-1000®
Treatment with 10 J/cm²
Device: Active laser therapy
Laser therapy at predetermined sites
Other Name: Low level laser therapy

Sham Comparator: Device: Sham LiteCure
Sham i.e. visible red light
Device: Sham laser therapy
Sham therapy at predetermined sites




Primary Outcome Measures :
  1. Pain intensity (100 mm VAS) Worst during the past week [ Time Frame: Baseline to 6 months after treatment ]
    Change from baseline to follow-up

  2. P4-test Pressure (1, 5, 10 or 15kg) added to provoke sacral pain [ Time Frame: Baseline to 6 months after treatment ]
    Change from baseline to follow-up

  3. 6 minute walk test, 6MWT, distance (m) [ Time Frame: Baseline to 6 months after treatment ]
    Change from baseline to follow-up

  4. Disability rating index, DRI. Function past week % [ Time Frame: Baseline to 6 months after treatment ]
    Change from baseline to follow-up


Secondary Outcome Measures :
  1. Pain score (0-26) of provoked pain on intra-pelvic anatomical landmarks [ Time Frame: Baseline to 6 months after treatment ]
    Change from baseline to follow-up

  2. SF-36, questionnaire [ Time Frame: Baseline to 6 months after treatment ]
    Change in quality of life from baseline to follow-up

  3. Pelvic Girdle Questionnaire, PGQ, function % [ Time Frame: Baseline to 6 months after treatment ]
    Change in function from baseline to follow-up

  4. Timed Up and Go Test,TUGT, time (s) [ Time Frame: Baseline to 6 months after treatment ]
    Change in seconds from baseline to follow-up

  5. Isometric muscle tests, isometric endurance (s) [ Time Frame: Baseline to 6 months after treatment ]
    Change in seconds from baseline to follow-up



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. A positive urinary human Chorionic Gonadotropin (hCG) test
  2. Nerve root affection in the lumbo-sacral spine
  3. Inflammatory disease with pelvic bone and/or spinal manifestation
  4. Known endometriosis, gynaecologic cancer or ongoing malign disease
  5. Previous surgery of the lumbar spine
  6. Corticosteroid treatment during the past 6 months and during treatment
  7. Incapacity to complete the questionnaires
  8. Age <18 years
  9. Body mass index ≥35 kg/m2
  10. Intolerance to the treatment dose or negative reactions of the laser treatment
  11. A new pregnancy, during treatment or between the follow-ups.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789735


Contacts
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Contact: Thomas Torstensson, PhD +46706248905 thomas.torstensson@pubcare.uu.se
Contact: Per Kristiansson, AssProf, PhD +46184716308 per.kristiansson@pubcare.uu.se

Locations
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Sweden
Sundsvall Hospital Recruiting
Sundsvall, Sweden, SE-85651
Contact: Thomas Torstensson, PhD    +46706248905    thomas.torstensson@pubcare.uu.se   
Contact: Anne Lindgren, MSc       anne.lindgren@pubcare.uu.se   
Sponsors and Collaborators
Uppsala University
Investigators
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Study Director: Per Kristiansson, AssProf, PhD Uppsala University
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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT02789735    
Other Study ID Numbers: LLLT
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Uppsala University:
Pregnancy
laser therapy
persistent pain
pelvic pain
Additional relevant MeSH terms:
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Pelvic Girdle Pain
Musculoskeletal Pain
Pain
Neurologic Manifestations
Pelvic Pain