Pregnancy-related pelvic girdle pain and massage

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2019
INTERVENTION: Remedial Pregnancy Massage Arm. Treatment will consist of remedial massage techniques specifically for pregnant women to the pelvis with the addition of treatment to the lumbar spine or adductors depending on presentation. All participants will receive 2 x 60‐minute massage treatments Treatments will be spaced between 7 and 11 days apart. CI Fogarty, a qualified massage therapist, will be administering the massage. A treatment form will be completed to describe the treatment received and to log treatemnts. The washout period between treatments is 11‐14 days. CONDITION: Musculoskeletal ‐ Other muscular and skeletal disorders Pregnancy‐related pelvic girdle pain; ; Pregnancy‐related pelvic girdle pain Reproductive Health and Childbirth ‐ Antenatal care Reproductive Health and Childbirth ‐ Other reproductive health and childbirth disorders PRIMARY OUTCOME: Feasibility ‐ crossover study design methodology; Statistical analysis will determine any period or carry over effects and the information used to guide future wash out periods and study design. Data used in the crossover analysis will include the self‐administered outcome measures: pain perception on a pain intensity‐numeric rating scale (PINR) (pre and post treatment and 1‐week post final treatment), function (The Pelvic Girdle Questionnaire) (pre treatments and 1‐week post final treatment), quality of life (The Short Form Health Survey (SF‐36) (25) (pre treatments and 1‐week post final treatment).[Analysis stage of the trial.] Feasibility ‐ participant sub‐characteristics; Participants sub characteristics – The presentation of PPGP can differ between participants and this will be investigated via the following participant sub characteristics:; • Number of sites of pelvic girdle (1‐2 sites of pain versus three or more sites); • Positive pain reproduction testing versus negative pain reproduction testing; • Those with PPGP and lumbar pain versus PPGP and no lumbar pain[Analysis stage of the trial from data collected at each treatment (Client History and Examination forms)] Feasibility ‐ recruitment and retention rates; • Recruitment – Information will be collected about where participants are recruited from to determine future advertising strategies. Information will be collected on the reason and number of people excluded from the study to determine inclusion/exclusion criteria for future studies. (Information gathered on the PPGP Study Participant Requirement Form).; • Retention – Information will be collected on the reasons for participant drop out to determine any potential issues with participant retention.[This information will be collected during the recruitment and enrolment stage of the study plus post study completion (participant retention). ] SECONDARY OUTCOME: Patient satisfaction will be measured using the Patient Satisfaction Questionnaire Short‐Form (PSQ‐18) (1‐week post final treatment). [1‐week post final treatment of each arm.] The acceptability of the outcome measures including pain, disability and quality of life. This is a composite outcome assessed via a post intervention questionnaire (designed by the researchers involving qualitative/quantitative questions such as such as ‘did the study questionnaires capture the symptoms and impact the PPGP had on you physically, emotionally and psychologically?).[1‐week post final treatment of each arm.] INCLUSION CRITERIA: Women 18 years of age or greater, between 13 and 30 weeks of pregnancy (i.e. able to get on and off the floor/massage table). Participants with both low back pain and pregnancy‐realted pelvic girdle pain (PPGP) will be included in the study. Participants will be eligible if they have sought treatment for their PPGP prior to enrolling in the study but will need to cease physiotherapy, massage, osteopathic, and/or chiropractic treatment while participating in the study.
Epistemonikos ID: fe558a0d0cab26cf0d8136a77e5f14527d7166f2
First added on: Aug 24, 2024