Effects of Pelvic Belt and Kinesio Tape on Pain and Functional Mobility in Pregnancy-Related Pelvic Girdle Pain
- Conditions
- Pelvic Girdle Pain
- Interventions
- Other: Kinesio tape (KT)Other: Pelvic belt (PB)Other: Educational program
- Registration Number
- NCT04266184
- Lead Sponsor
- Muğla Sıtkı Koçman University
- Brief Summary
This study investigates the effects of pelvic belt (PB) and kinesio taping (KT) applications on pain and functional mobility in pregnancy-related pelvic girdle pain (PGP), in comparison with the control group that received only pain neuroscience education and ergonomic training.
- Detailed Description
Although there is strong evidence in the literature that pelvic support belts reduce pain in pregnancy-related pelvic girdle pain, no study investigating its effect on functional mobility with performance-based measurement methods or investigating its effectiveness on kinesiophobia has been found. Studies investigating the efficacy of KT in pregnant women with PGP are few and many are methodologically weak studies, most of which do not contain randomization and control groups. Also, no study has been found in the literature, which compares the effectiveness of PB and KT in pregnant women with PGP. Therefore, the primary aim of this study is to examine the effects of PB and KT on pain and functional mobility in pregnant women with PGP in comparison with the control group, which is only given pain neuroscience education and ergonomic training. The secondary aims are to investigate the effects of these applications on kinesiophobia, activity limitation and sleep quality; and to compare the groups in regard to patient compliance and treatment satisfaction levels of the groups.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 47
- being able to read and write in Turkish
- being in 2nd or 3rd trimester of pregnancy
- having PGP for more than one week
- signing the informed consent form for the study
- visual, auditory or cognitive problems which may prevent participation to the study
- health problems other than pregnancy-related PGP (orthopedic, neurologic, cardiorespiratory, etc.) or trauma history, which may affect standing from sitting, walking or stair climbing activities
- any gynecological or urological problems which may mimic pregnancy related PGP
- any diagnosed pregnancy complications other than PGP (preeclampsy, hypertension, diabetes,placental/fetal anomaly, preterm labor, etc.)
- high risk pregnancy (multiple gestation, etc.)
- history of spinal injury, ankylosing spondilitis, rheumatoid arthritis, intervertebral disc pathology)
- A positive straight leg raise test result, as well as sensory or motor deficits indicating intervertebral disc pathology
- history of prepregnancy low back or pelvic girdle pain
- using any analgesic or myorelaxant medication
- contraindications to KT or PB (impaired skin integrity or lesion in the lumbopelvic and abdominal regions, history of allergic reaction, etc.)
- previous KT (abdominal or lumbosacral) or PB experience
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Kinesio tape (KT) Kinesio tape (KT) Abdominal and symphisis pubis supported lumbopelvic KT will be applied. This group will also receive the same educational program with the control group. Pelvic belt (PB) Pelvic belt (PB) A narrow and flexible adjustable pelvic belt will be used in high position (just under the spina iliaca anterior superior). This group will also receive the same educational program with the control group. Kinesio tape (KT) Educational program Abdominal and symphisis pubis supported lumbopelvic KT will be applied. This group will also receive the same educational program with the control group. Pelvic belt (PB) Educational program A narrow and flexible adjustable pelvic belt will be used in high position (just under the spina iliaca anterior superior). This group will also receive the same educational program with the control group. Control group Educational program This group will receive a 1-hour educational program composed of neuroscience education and ergonomic training.
- Primary Outcome Measures
Name Time Method change in pain intensity during five-stairs climbing test baseline, approximately one-hour after the first intervention, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention The women will be asked to mark their pain intensity during five-stairs climbing test. 0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used.
change in pain intensity during timed up and go test baseline, approximately one-hour after the first intervention, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention The women will be asked to mark their pain intensity during timed up and go test. 0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used.
change in general pain intensity during activity baseline, approximately one-hour after the first intervention, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention The women will be asked to mark their pain intensity during activities in general. 0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used.
change in pain intensity during five times sit to stand test baseline, approximately one-hour after the first intervention, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention The women will be asked to mark their pain intensity during five times sit to stand test. 0 (no pain)-10 cm (unbearable pain) visual analogue scale will be used.
change in impairment during active straight leg raise test baseline, approximately one-hour after the first intervention, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention The women will be asked to score their impairment during active straight leg raise test. 0 (not difficult at all)-5 (unable to do) scoring system will be used. Scores for right and left legs will be summed and recorded.
- Secondary Outcome Measures
Name Time Method change in activity limitation baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention Turkish version of Pelvic Girdle Questionnaire will be used. Total score varies between 0 and 75, and higher score indicates higher activity limitation.
change in kinesiophobia baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention Turkish version of Tampa Kinesiophobia Scale will be used. The score ranges between 17 and 68, and higher score indicates higher kinesiophobia.
treatment satisfaction baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention Treatment satisfaction will be assessed by 0 (not at all)-10 (extremely satisfactory) cm VASs.
change in sleep quality baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention Quality of sleep will be assessed on a 0 (very bad)-10 (very good) cm VAS.
patient compliance baseline, three days after the first intervention, one week after the first intervention, and one week after cessation of intervention For PB and KT groups, comfort and easiness of using PB and KT will be assessed by 0 (not at all)-10 (extremely comfortable/easy) cm VASs. All groups will be questioned about the comprehensibility of the educational program on 0 (not at all)-10 (completely comprehensible) cm VASs. Also, degree of following the suggestions given in the educational program will be evaluated by 0 (not at all)-10 (completely) cm VASs.
Trial Locations
- Locations (1)
Bezmialem Vakıf University
🇹🇷Istanbul, Turkey