Pelvic Girdle Pain Clinical Trial
Official title:
Effectiveness of Low Level Laser Therapy in Persistent Pregnancy-related Pelvic Girdle Pain After Childbirth
NCT number | NCT02789735 |
Other study ID # | LLLT |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | April 2021 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | April 2021 |
Est. primary completion date | February 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Sundsvall Hospital | Sundsvall |
Lead Sponsor | Collaborator |
---|---|
Uppsala University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain intensity (100 mm VAS) Worst during the past week | Change from baseline to follow-up | Baseline to 6 months after treatment | |
Primary | 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 | |
Primary | 6 minute walk test, 6MWT, distance (m) | Change from baseline to follow-up | Baseline to 6 months after treatment | |
Primary | Disability rating index, DRI. Function past week % | Change from baseline to follow-up | Baseline to 6 months after treatment | |
Secondary | Pain score (0-26) of provoked pain on intra-pelvic anatomical landmarks | Change from baseline to follow-up | Baseline to 6 months after treatment | |
Secondary | SF-36, questionnaire | Change in quality of life from baseline to follow-up | Baseline to 6 months after treatment | |
Secondary | Pelvic Girdle Questionnaire, PGQ, function % | Change in function from baseline to follow-up | Baseline to 6 months after treatment | |
Secondary | Timed Up and Go Test,TUGT, time (s) | Change in seconds from baseline to follow-up | Baseline to 6 months after treatment | |
Secondary | Isometric muscle tests, isometric endurance (s) | Change in seconds from baseline to follow-up | Baseline to 6 months after treatment |
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