Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06135142
Status:
RECRUITING
Last Update Posted:
2023-11-21
First Post:
2023-11-07
Brief Title:
Connective Tissue Massage And Classical Massage In Patients With Chronic Non-Specific Low Back Pain
Sponsor:
Cansu DAL
Organization:
Muğla Sıtkı Koçman University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n10 connective tissue massage n10 and control groups n10 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
Methods The study included 30 participants diagnosed with chronic non-specific low back pain Participants were randomly divided into three groups classical massage n10 connective tissue massage n10 and control groups n10 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 09012020 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 reporting11 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 n10 CM group n10 and control group n10 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 CD 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
All treatment sessions were administered by the same investigator CD 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None