Clinical Trial: Low Level Laser Therapy in Persistent Pelvic Girdle Pain

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effectiveness of Low Level Laser Therapy in Persistent Pregnancy-related Pelvic Girdle Pain After Childbirth

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.

Detailed Summary:

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.

A total of 60 women will be sampled consecutively. Women eligible to participate will be those women who were registered at a maternal health care unit in the municipalities of Sundsvall and Timrå with subsequent childbirth registered at the Sundsvall-Härnösand County Hospital, Sweden. An invitation letter with a prepaid response envelope will be sent by postal mail to the eligible women by contact information retrieved from the labour ward. Women who respond will be enrolled and approve their participation by signed informed consent. The women will be included in the study according to inclusion and exclusion criteria following a baseline assessment that comprises a urinary test, questionnaires and clinical examination. After inclusion a blood sample, for serum and plasma, will be drawn at inclusion and directly after the treatment period.

Randomisation and blinding The randomisation sequence will be generated by a statistician not involved in the study. Randomisation will be done using block randomisation (block size 4 or 6) without stratification. The investigators will use sequentially numbered, opaque, sealed envelopes which have been pre-prepared in advance by the statistician. Women who fulfil the inclusion criteria will be randomised to active laser treatment or sham laser treatment. A research assistant not involved in the inclusion assessments will perform the randomisation, prepare and handle the allocated treatment device before and after each treatment session. The treatment will be given
Sponsor: Uppsala University

Current Primary Outcome:

• Pain intensity (100 mm VAS) Worst during the past week [ Time Frame: Baseline to 6 months after treatment ]
  Change from baseline to follow-up
• 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
• 6 minute walk test, 6MWT, distance (m) [ Time Frame: Baseline to 6 months after treatment ]
  Change from baseline to follow-up
• Disability rating index, DRI. Function past week % [ Time Frame: Baseline to 6 months after treatment ]
  Change from baseline to follow-up

Original Primary Outcome:

• Pain intensity (100 mm VAS) Worst during the past week [ Time Frame: Baseline, 1 week after treatment, 3 months after treatment, 6 months after treatment ]
  Change from baseline to follow-ups and between follow-ups
• P4-test Pressure (1, 5, 10 or 15kg) added to provoke sacral pain [ Time Frame: Baseline, 1 week after treatment, 6 months after treatment ]
  Change from baseline to follow-ups and between follow-ups
• 6 minute walk test, 6MWT, distance (m) [ Time Frame: Baseline, 1 week after treatment, 6 months after treatment ]
  Change from baseline to follow-ups and between follow-ups
• Disability rating index, DRI. Function past week % [ Time Frame: Baseline, 1 week after treatment, 3 months after treatment, 6 months after treatment ]
  Change from baseline to follow-ups and between follow-ups

Current Secondary Outcome:

• 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
• SF-36, questionnaire [ Time Frame: Baseline to 6 months after treatment ]
  Change in quality of life from baseline to follow-up
• Pelvic Girdle Questionnaire, PGQ, function % [ Time Frame: Baseline to 6 months after treatment ]
  Change in function from baseline to follow-up
• Timed Up and Go Test,TUGT, time (s) [ Time Frame: Baseline to 6 months after treatment ]
  Change in seconds from baseline to follow-up
• Isometric muscle tests, isometric endurance (s) [ Time Frame: Baseline to 6 months after treatment ]
  Change in seconds from baseline to follow-up

Original Secondary Outcome:

• Pain score (0-26) of provoked pain on intra-pelvic anatomical landmarks [ Time Frame: Baseline and 6 months after treatment ]
  Change from baseline to follow-up 6 months
• SF-36, questionnaire [ Time Frame: Baseline, 1 week after treatment, 3 months after treatment, 6 months after treatment ]
  Change in quality of life from baseline to follow-ups and between follow-ups
• Active straight leg raising, ASLR, score 0-10 [ Time Frame: Baseline, 1 week after treatment, 6 months after treatment ]
  Change in score from baseline to follow-ups and between follow-ups
• Pelvic Girdle Questionnaire, PGQ, function % [ Time Frame: Baseline, 1 week after treatment, 3 months after treatment, 6 months after treatment ]
  Change in function from baseline to follow-ups and between follow-ups
• Timed Up and Go Test,TUGT, time (s) [ Time Frame: Baseline, 1 week after treatment, 6 months after treatment ]
  Change in seconds from baseline to follow-ups and between follow-ups
• Isometric muscle tests, isometric endurance (s) [ Time Frame: Baseline, 1 week after treatment, 6 months after treatment ]
  Change in seconds from baseline to follow-ups and between follow-ups

Information By: Uppsala University

Dates:
Date Received: April 8, 2016
Date Started: March 2016
Date Completion: June 2018
Last Updated: February 21, 2017
Last Verified: February 2017