Pelvic Girdle Pain Clinical Trial
Official title:
Effectiveness of Low Level Laser Therapy in Persistent Pregnancy-related Pelvic Girdle Pain After Childbirth
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.
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 by a physiotherapist who is blinded to treatment group, the
women's case history, questionnaires and clinical examinations.
All collected data will be handled, stored and analysed at the Department of Public Health
and Caring Sciences at Uppsala University. The analysts will be blinded to the treatment
allocation until data of primary outcomes have been analysed and conclusions have been drawn
and signed in writing before the code is broken.
Questionnaires At baseline, the women will complete questionnaires which include questions on
socio-demographic data, somatic and mental health, gynaecological and obstetric history, and
lifestyle.
At baseline and follow-ups, the women will report present pain distribution on a pain drawing
(including onset and modality of pain). Pain intensity at present and as worst during the
past week will be measured by a 100 mm VAS (Visual analogue scale). Functioning will be
assessed by Disability Rating Index (DRI), Pelvic Girdle Questionnaire (PGQ) and Short Form
36 (SF-36). Throughout the treatment period, the women will daily record pain intensity in a
pain diary by use of a 100 mm VAS.
At the follow-up after the treatment period the women will complete a Global Perceived Effect
scale, report any adverse event, and report their opinion on whether or not they have
received active treatment.
Clinical examination The two assessors, a gynaecologist and a physiotherapist, will perform
the examinations without knowledge of assigned treatment, the women's case history,
questionnaire replies and clinical examinations. The test procedure and test sequence will be
the same throughout the study.
A gynaecologic examination, including an ultrasound examination, will be performed by a
gynaecologist at baseline. Provoked pain by a gentle pressure on the following 13
predetermined intra-pelvic anatomical landmarks will be assessed via vaginal palpation: the
coccyx, the lateral part of sacrum at the insertion of the sacrospinous ligament, the middle
part of the sacrospinous ligament, the insertion of the sacrospinous ligament at the
ischiadic spine, the ischium inferior to the ilio-ischial fusion and the lateral and medial
part of the pubic bone. All the structures will be examined bilaterally except for the
coccyx.
The musculoskeletal examinations at baseline and follow-ups will be performed by a
physiotherapist. It will include examination of the lower back spine, pelvis and assessment
of physical functioning. Briefly, the lower back spine will be examined by palpation of
ligaments and paravertebral muscles, Kemp's foramina test, Valsalva test, SLR (straight leg
raising test) and test of tendon reflexes and sensibility. The pelvis will be examined by the
following tests: P4 test, Menell's test, Patrick's faber test, modified Trendelenburg test
and the pubic symphysis palpation test.
Pain provocation tests will be considered positive if they duplicate or aggravate pain from
the sacral area on the tested side, otherwise negative. The women will grade the provoked
pain on a 100 mm VAS scale.
Physical functioning will be assessed at baseline and follow-up by the Six Minute Walk Test
(6MWT), the Timed Up and Go Test (TUGT), the Active Straight Leg Raising Test (ASLR) and
isometric trunk muscle tests.
Urine and blood sampling A urinary test will be sampled for test of hCG, human Chorionic
Gonadotropin (pregnancy), at time of inclusion. A blood sample, for serum and plasma, will be
drawn at inclusion and directly after the treatment period. The blood samples will be
analysed directly for estrogen, progesterone, testosterone, sexual binding globulin, thyroid
stimulating hormone and prolactin and thereafter discarded.
Treatment regimen The treatment comprises 12 treatment sessions distributed as one treatment
daily at three consecutive days during the first treatment week and then three times a week
every other weekday during the next three weeks. The treatment will be given by a licensed
physiotherapist blinded for the allocated treatment. The treatment will start immediately
after a menstrual period or within one week's time among women with regained menstrual
periods, otherwise at any time convenient.
Throughout the treatment period the women will be asked to avoid pain provoking activities,
the use of corticosteroid treatment, and sexual intercourse without use of safe
contraception. Before each treatment the women will sign a form stating no unprotected
intercourse since last treatment session. The women report use of pain medication and
physical activity at the end of the treatment period.
Treatment equipment and performance A class IV low level laser (LiteCure LCT-1000®) and a
similar sham laser will be used. Both devices are delivered by LiteCure, LLC, Newark, DE,
USA. The active device delivers its energy by two wavelengths, 20% of the beam with 810 nm
(nanometer) and 80% of the beam with 980 nm. Energy given will be tested before the start of
the study and once every month, using Thor labs power meter PM100D and the photo sensor S 121
C, to make sure the device works correctly. There is also a red aiming beam with a wavelength
of 650 nm and a power of 5 mW (milliwatt). The sham laser delivers solely the aiming beam.
The treatment is applied to the sacral region by a standard laser probe with a 26 mm quarts
ball at the top, and to the internal pelvis by a 16 cm long fibre-containing transvaginal
probe with a diameter of the bulb-shaped end of 18 mm. The physical therapist and the
participant use safety eyewear during all treatment sessions and the treatment administration
area is closed, have restricted access and no reflective surfaces.
During treatment at sacral points, the standard probe is moved 1 cm/second from a starting
point to an end-point repeatedly during treatment time, bilaterally. The standard probe is
held perpendicular to the body surface and pressed to the skin.
During treatment vaginally the physiotherapist palpates the anatomical landmarks by vaginal
palpation to guide the transvaginal probe and hold it still on the treatment sites. Due to
reasons of hygiene the transvaginal probe is covered by transparent plastic cover during
treatment. The plastic cover is discarded and both probes are cleaned with ethanol-based
surface disinfection after treatment.
Treatment locations on the outside of the pelvis The treatment on the outside of the pelvis
is given on three sites defined by a given starting point and a treatment area. The starting
point of treatment is described by vertical and horizontal coordinates.
Treatment locations on the inside of the pelvis
The treatment sites inside the pelvis are:
1. the sacrospinous ligament at the insertion on the ischial spine
2. at the middle of the sacrospinous ligament
3. the sacrospinous ligament at the insertion on the sacrum medially and in the level of
the ischial spine
Treatment dose To deliver an appropriate dose of energy according to the best available
evidence and experience, the active treatment group received LLLT with a dual wavelength of
810 nm and 980 nm and a dose of 10 J/cm² vaginally and 10 J/cm² over the sacral areas. The
control group will receive sham treatment by a red aiming beam with a power of 5 mW with the
same treatment time as the active treatment.
If a woman experiences a negative reaction or does not tolerate the treatment dose, the
treatment will immediately be stopped. The amount of energy given at each treatment session
will be recorded.
Data analysis Power calculation To show a statistically significant difference of at least 20
mm in pain intensity (considered as a clinically relevant difference) measured by visual
analogue scale between the active treatment group and the control group, at least 32 women
will be needed with the assumptions of type I error of 5% and type II error of 20%. To take
account for data loss the investigators aim at a sample size of at least 30 women in each
group, in total 60 women.
Statistical analysis The analyses of outcomes will be performed in accordance with the
European Medicines Agency's Statistical Principles for Clinical Trials guidelines.
Differences between the treatment groups regarding outcome measures will be analysed by
regression analysis of variance on ranks. Other parametric and non-parametric statistical
methods will be used whenever appropriate. Two-sided tests will be used and 5% statistical
significance level will be chosen for all analyses. To provide unbiased comparisons between
the groups the investigators will be perform an intention-to-treat analysis. Also, a
per-protocol analysis on the women who complete the study according to the protocol will be
performed.
Ethical considerations The use of the LLLT devices is approved by Swedish and European
authorities (Reference number 2014/188, dated140811) and is supposed to have minimal side
effects. The present study is approved by the Regional Ethical Review Board in Uppsala (Dnr
2014 / 188). All women will sign an informed consent.
To prevent potential injury or harm, the vaginal probe will be used with care. Also, a
gynaecologic examination will be performed before start of study treatment. The effect of low
level laser irradiation to an early pregnancy is not known; therefore potential harm will be
sought minimised by a test of hCG at study inclusion. Also written statements of no sexual
intercourse without safe contraception will be given before each treatment session.
The physical therapist and the participant will use safety eyewear during all treatment
sessions and the treatment administration area will be closed, have restricted access and
will be without reflective surfaces. Finally, our perception is that the advantages of the
study treatment outweigh ethical problems. All of the researchers declare no conflict of
interest.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT03541343 -
GreenBRIC Clinical Trial
|
N/A | |
Completed |
NCT04873778 -
Comparing Effects of Kinesio and Dynamic Tapings in Postpartum Women With Pelvic Girdle Pain
|
N/A | |
Completed |
NCT04981418 -
Evaluating the Management of Chronic Pelvic Girdle Pain
|
N/A | |
Terminated |
NCT02044991 -
Ultrasound Guided Posterior Sacroiliac Ligament Corticosteroid Injection in Pregnancy-Related Pelvic Girdle Pain
|
Phase 2 | |
Recruiting |
NCT06284278 -
Telehealth: Diaphragmatic vs. Pelvic Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain
|
N/A | |
Completed |
NCT05181384 -
Pelvic Floor Muscles and Stabilization Integrated Training Improved Pregnancy-related Pelvic Girdle Pain
|
N/A | |
Withdrawn |
NCT04377516 -
Effects of Specific Pelvic Stabilization Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain Women
|
N/A | |
Not yet recruiting |
NCT05507853 -
Exploring Central Sensitization in Pregnant Women
|
||
Completed |
NCT03518840 -
Predictive Value of the Active Straight Leg Raise on the Efficacy of a SJB in Posterior PGP During Pregnancy
|
N/A | |
Recruiting |
NCT05879575 -
Effects and Pathophysiology of Weight Training on Pregnancy-related Pelvic Girdle Pain (PPGP)
|
N/A | |
Completed |
NCT03261687 -
The Effects of a Water Based Exercise Programme and a Land Based Exercise Programme on Women Experiencing Pregnancy Related Pelvic Girdle Pain
|
N/A | |
Active, not recruiting |
NCT05382845 -
Screening for Pregnancy Related Pelvic Girdle Pain
|
N/A | |
Active, not recruiting |
NCT03606720 -
Effect of Low Level Laser Therapy and Pelvic Stabilisation Exercises on Postpartum Pelvic Girdle Pain
|
N/A | |
Completed |
NCT02543515 -
Psychosocial and Clinical Characteristics Predicting Women's Acceptance of Office Hysteroscopy
|
N/A | |
Completed |
NCT01098136 -
Pelvic Girdle Pain in a Pregnant Population in Western Norway.
|
N/A | |
Completed |
NCT03436888 -
Cross-cultural Adaptation and Validation of the Pelvic Girdle Questionnaire in French Language
|
||
Recruiting |
NCT04266184 -
Effects of Pelvic Belt and Kinesio Tape on Pain and Functional Mobility in Pregnancy-Related Pelvic Girdle Pain
|
N/A | |
Not yet recruiting |
NCT05403437 -
Pelvic Girdle Pain Symptom Severity in Pregnant Women With Gestational Diabetes Mellitus
|
||
Not yet recruiting |
NCT05403424 -
Biomechanical and Viscoelastic Properties of Thoracolumbar Fascia in Pregnancy Pelvic Girdle Pain
|
||
Recruiting |
NCT04226716 -
The Role of Proprioceptive Deficits and Psychosocial Factors in Pregnancy-related Pelvic Girdle Pain: a Follow-up Study
|
N/A |