Connective Tissue Massage And Classical Massage In Patients With Chronic Non-Specific Low Back Pain.

Low Back Pain Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06135142
• Other study ID #: CD1
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2023
• Est. completion date: December 10, 2023

Study information

• Verified date: November 2023
• Source: Mugla Sitki Koçman University
• Contact: Cansu DAL
• Phone: 5379773071
• Email: ptcansudal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 10, 2023
• Est. primary completion date: December 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Connective Tissue Massage
It involves manipulating the soft and deep tissues of the body.

Device:
• Transcutaneous Electrical Nerve Stimulation (TENS)
The sum of therapeutic modalities of physical medicine capable to change the threshold of elicitation of nerve or muscle.

Other:
• Classical Massage
It involves manipulating the soft tissues of the body.

Device:
• Therapatic Ultrasound
The sum of therapeutic modalities of physical medicine capable to change the threshold of elicitation of nerve or muscle.

Other:
• Heat Treatment
Applying heat to an affected area to treat damaged muscles, joints or tissues in the body.

Locations

Country	Name	City	State
Turkey	Bayindir Devlet Hastanesi	Izmir	Bayindir

Sponsors (1)

Lead Sponsor	Collaborator
Cansu DAL

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	The VAS is a widely used, valid, and reliable measurement method for assessing pain intensity. It consists of a horizontal line drawn to a length of 10 cm, with the numbers 0 and 10 located at the left and right ends, respectively. Zero represents "no pain at all," while 10 represents "the most severe pain imaginable." As one moves from left to right along the line, the intensity of pain increases. The patient is asked to mark on the VAS where their current pain intensity lies, based on how they feel at the moment of assessment. The measurement is then recorded in centimeters using a ruler .	4 weeks
Primary	Modified Schober Test (MST)	The MST is used to assess lumbar mobility in patients. Two Spina iliaca posterior superior landmarks are identified and connected by drawing a line to mark the midline. A point is marked 10 cm above and 5 cm below this midline. The distance between these two points should be 15 centimeters. Subsequently, the patient is asked to bend forward from the waist without bending the knees. While bending, the distance between the same two points is measured again, and the amount of change is calculated.	4 weeks
Primary	Sit and Reach Test (SRT)	The SRT, can be utilized to assess trunk mobility or flexibility in patients with back pain. The test was performed by sit and reach box with a measuring scale. The test involved sitting on the floor with legs stretched out straight ahead. The soles of the feet were placed flat against the box. Both knees were locked and pressed flat to the floor. With the palms facing downward and the hands on top of each other, the subjects reached forward along the measuring line as far as possible. The points reached by the patients were marked and recorded.	4 weeks
Primary	Back Pain Functional Scale (BPFS)	The BPFS is a 12-item scale used to assess how patients' activities and functions are affected by their current back pain complaints. The scale evaluates activities related to work, school, household tasks, general habits, forward bending, putting on shoes/socks, lifting objects from the ground, sleeping, sitting, standing, walking, stair climbing, and driving a car. For patients who do not drive, the final question can be answered as "travelling." Each statement is scored from 0 to 5, with a maximum score of 60 and a minimum score of 0. Higher scores indicate less difficulty in performing functional activities.	4 weeks
Primary	Roland Morris Disability Qustionnaire (RMDQ)	The RMDQ, is a patient-administered scale consisting of 24 items used to assess patients' functional status.Patients are asked to respond to statements that correspond to their current condition, leaving blank spaces for statements that do not apply to them. Each answered statement is assigned a score of 1, and the total score of the questionnaire is calculated. The change in the total questionnaire score is used to determine the clinical improvement rate.	4 weeks
Primary	Short Form-36 Questionnaire (SF-36)	The SF-36 is a patient-administered questionnaire consisting of 36 items used to assess an individual's quality of life. It includes two sections, namely physical health (physical functioning, physical role, pain, general health) and mental health (vitality, social functioning, emotional role, mental health), with a total of eight subdomains. Each subdomain is scored on a scale of 0 to 100. Higher scores indicate better health status.	4 weeks