The Short-term Effects of Taping During Pregnancy-related Low Back Pain, Pelvic Girdle Pain or Combined Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 96
- 主要终点
- Change from baseline Oswestry Back Disability Index (ODI) to ODI 5-7 days later
研究概览
简要总结
Back pain during pregnancy is common with up to 90% of pregnant women experiencing either low back pain (PLBP), pelvic girdle pain (PGP) or a combination of both pains. Although pregnant women seek out various forms of pain relief methods such as pain medication, exercise, education, pelvic support belts, and chiropractic treatments, there is limited evidence with regards to the efficacy of these treatments. Recently manual therapists, such as chiropractors, have used tape in an effort to relieve pain from musculoskeletal injuries with varying results. In the pregnant population, there have been limited studies to date on the role of taping and pregnancy-related back pain and none of this research delineates the efficacy of tape with respect to the 3 pain patterns experienced by pregnant women.
详细描述
This study is a randomized control trial with 3 main parts associated. 1) Initial visit: Potential participants will be recruited from 2 antenatal clinics at the participating hospital. A person from the circle of care will ask if they are interested in participating in a study regarding pregnancy-related LBP. Participants are pre-screened by a research investigator, If patients meet the eligibility criteria, they will be invited to participate. Research personnel will explain the study in full including the rationale (per the Project Consent Form), visit requirement, treatment protocol and follow-up. Once consent is obtained, a Pre-Visit Questionnaire will be administered while they are awaiting their antenatal appointment. 2) Physical exam and treatment: Following their appointment, research personnel will walk the participant to the Obstetrical Day Unit where the chiropractor will review the consent and questionnaire, perform a brief physical exam to ensure proper stratification of pain, randomized the participant (as pre-determined by the biostatistician) and apply the appropriate taping protocol (intervention vs sham). 3) Follow-up: Five to 7 days later, research personnel will follow-up with the participant by phone and administer a questionnaire pertaining to their experience with the taping protocol. The total visit should take no more than 30 minute
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Once consent has been obtained the senior chiropractors will review the intake questionnaire with the patients, ask any pertinent questions they may have regarding the patient's personal medical history and current pain pattern and perform a physical exam to differentiate pain patterns for each participant.
Following completion of baseline assessment and consent, participants will be stratified by their type of pain presentation and then be randomly allocated to 1 of the 2 intervention arms. Central randomization will be performed using stratified block randomization by the study biostatistician (SHJ) using SAS software*. To ensure that the allocation sequence is concealed from the researchers varying block sizes of 2, 4 and 6 will be used and the biostatistician will provide the trial coordinator with 3 series (1 for each stratum) of sequentially numbered sealed opaque envelopes containing the intervention allocations.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy females of childbearing age
- •Currently experiencing a healthy, singleton pregnancy and are at 28 weeks of gestation or later
- •Proficient competency in the English language
排除标准
- •Does not wish to participate
- •Carrying multiples
- •Inability to understand the questionnaire due to a lack of understanding of the English language
- •Allergy to tape and/or adhesives (acrylic copolymer)
- •Prior spinal surgery
- •A known and current disc pathology
研究组 & 干预措施
Intervention Tape
The intervention includes 3 strips of tape; 2 (1 on each side) placed vertically along the lumbar erectors and 1 horizontally at the posterior superior iliac spine.
Subjects will wear the tape for as long as possible up to 5-7 days.
干预措施: Tape (Other)
Sham Tape
One strip of tape will be applied horizontally to the thoracolumbar junction.
Subjects will wear the tape for as long as possible up to 5-7 days.
干预措施: Sham Tape (Other)
结局指标
主要结局
Change from baseline Oswestry Back Disability Index (ODI) to ODI 5-7 days later
时间窗: 7 days
Measure of a patient's functional disability
Change from baseline Numeric Pain Scale (Pain) to Numeric Pain Scale (Pain) 5-7 days later
时间窗: 7 days
Intensity of pain on a 0-10 scale; 0=no pain; 10=most severe pain
次要结局
未报告次要终点
研究者
Carol Ann Weis
Researcher
Canadian Memorial Chiropractic College