Clinical trial NCT06135142: Connective Tissue Massage And Classical Massage In Patients With Chronic Non-Specific Low Back Pain.
Official title: Comparison Of The Effects Of Connective Tissue Massage And Classical Massage On Pain, Functional Status And Quality Of Life In Patients With Chronic Non-Specific Low Back Pain.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain
Connective Tissue Massage
Classical Massage
Lumbar Mobility
Quality of Life
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective This study aimed to compare the effects of connective tissue massage and classical massage on pain, functional status and quality of life in patients with chronic non-specific low back pain.

Methods The study included 30 participants diagnosed with chronic non-specific low back pain. Participants were randomly divided into three groups: classical massage (n=10), connective tissue massage (n=10), and control groups (n=10). The control group received standart physical therapy only. All interventions were administered over a period of 3 days per week for 4 weeks, with each session lasting approximately 15-20 minutes. All assessments were performed at baseline and at the end of 4 weeks. For all participants, the severity of pain was assessed using the Visual Analog Scale, the level of impaired function was measured using the Functional Low Back Pain Scale, lumbar mobility was evaluated with the Modified Schober Test and Sit and Reach Test, physical disabilities were gauged using the Roland Morris Disability Questionnaire, and the quality of life was assessed using the Short Form-36 Quality of Life questionnaire.

Detailed description: This was a 3-arm randomized controlled trial, parallel-group study with blind outcomes assessor. Ethical approval was obtained from the Muğla Sıtkı Koçman University Health Sciences Ethics Committee (09.01.2020, decision no: 4). Detailed information about the study was verbally provided to participants, and written informed consent was obtained. The study adhered to the ethical principles of the Helsinki Declaration. The study design adhered to the CONSORT guidelines for rigorous reporting.11 After obtaining consent and confirming the inclusion criteria, a convenience sample of 30 participants was equally and randomly divided into three groups: the CTM group (n=10), CM group (n=10), and control group (n=10). Randomization was carried out by an independent physical therapist, who was not involved in the assessment or treatment of the participants, 1 hour before the baseline measurements. The randomization process involved using opaque and sealed envelopes, each containing a group allocation number generated from a computer-generated random number table. Block randomization was employed to ensure an equal distribution of participants across the groups.

All treatment sessions were administered by the same investigator (C.D) in the study group. The intervention duration was uniform across all groups: 4 consecutive weeks, with 3 sessions per week lasting 15-20 minutes per session. Outcome measurements were taken at the beginning and 4 weeks after the completion of the program. An independent physiotherapist, unaware of the research details and participant groupings, conducted the evaluations.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65,
* Diagnosis of chronic non-specific low back pain,
* Rest or activity pain score of 3 or higher on the Visual Analog Scale (VAS).

Exclusion Criteria:

* Undergoing surgical operation within the last 6 months or having prior spinal surgery,
* Presence of spondyloarthropathy, spondylolisthesis, or lumbar stenosis,
* Systemic inflammatory disease,
* Usage of non-specific anti-inflammatory medication in the past 15 days
* Pregnancy.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 4 weeks
measure: Modified Schober Test (MST)
timeFrame: 4 weeks
measure: Sit and Reach Test (SRT)
timeFrame: 4 weeks
measure: Back Pain Functional Scale (BPFS)
timeFrame: 4 weeks
measure: Roland Morris Disability Qustionnaire (RMDQ)
timeFrame: 4 weeks
measure: Short Form-36 Questionnaire (SF-36)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Bayındır Devlet Hastanesi
state: Bayındır
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: Cansu DAL
role: PRINCIPAL_INVESTIGATOR
affiliation: Muğla Sıtkı Koçman University
name: Meltem KOÇ
role: STUDY_DIRECTOR
affiliation: Muğla Sıtkı Koçman University
name: Banu BAYAR
role: STUDY_DIRECTOR
References: