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

NCT06135142 | Unknown

• 1 other identifier: CD1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Low Back Pain; Connective Tissue Massage; Classical Massage; Lumbar Mobility; Quality of Life

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

Connective Tissue Massage Group

EXPERIMENTAL

The patient was positioned in sitting position and their feet were supported.The basic region consisted of short and long strokes to the anterior superior iliac spine, the sacrolumbar angle, the ilium, L5 to T12, the pectoral muscles.After,the transition was made to the lower thoracic region.Short strokes were applied from lateral to medial on the latissimus dorsi muscle.Short strokes were executed between the transverse processes of the vertebrae from T12 to T7.Following this,long strokes were initiated from the axilla and continued up to the vertebrae.Finally,long strokes continued beneath the scapular angles.At the end of the lower thoracic region massage,the pectoral muscles were subjected to three stroking motions.After concluding the massage of the lower thoracic region,the application was finalized with long strokes performed subcostally and under the iliac crest.

Other: Connective Tissue Massage

Classic Massage Group

EXPERIMENTAL

The patient positioned themselves face down with their upper clothing removed. The massage initiation involved employing a general stroking motion. Commencing from the sacrolumbar region, paravertebral long sweeping strokes were executed bilaterally, progressing upwards along the vertebrae's lateral edges. In the area spanning from the lumbothoracic boundary to the gluteals, a general stroking motion was iterated thrice. Subsequently, the erector spinae, latissimus dorsi, and gluteus maximus muscles were sequentially subjected to a series of actions: three cycles of stroking, followed by three cycles of kneading, concluding with three more cycles of stroking. As a concluding step, the initial general stroking movements were replicated thrice prior to finalizing the massage session.

Other: Classical Massage

Control Group

ACTIVE COMPARATOR

The standardized physiotherapy program included the application of superficial thermal heat, transcutaneous electrical nerve stimulation (TENS) and therapatic Ultrasound. TENS at a frequency of 100 Hz (250-μsec pulses) was applied for 15 min using two 4- to 6-cm electrodes placed bilaterally on each side of the spinous process of the L4 to S1 vertebrae with thermal therapy. While the TENS application was in progress, the heat treatment was also applied. Topical moist heat treatment at 40°C applied directly on the skin to increase both tissue temperature and blood flow. Then, continuous ultrasound was applied at an intensity of 1.5 to 2.5 W/cm2 for a period of 5 minutes.

Device: Transcutaneous Electrical Nerve Stimulation (TENS); Device: Therapatic Ultrasound; Other: Heat Treatment

Interventions

Connective Tissue Massage OTHER

It involves manipulating the soft and deep tissues of the body.

Connective Tissue Massage Group

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

The sum of therapeutic modalities of physical medicine capable to change the threshold of elicitation of nerve or muscle.

Control Group

Classical Massage OTHER

It involves manipulating the soft tissues of the body.

Classic Massage Group

Therapatic Ultrasound DEVICE

The sum of therapeutic modalities of physical medicine capable to change the threshold of elicitation of nerve or muscle.

Control Group

Heat Treatment OTHER

Applying heat to an affected area to treat damaged muscles, joints or tissues in the body.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cansu DAL: lead

Study Sites (1)

Bayındır Devlet Hastanesi

Izmir, Bayındır, 35840, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Transcutaneous Electric Nerve Stimulation; Diathermy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Hyperthermia, Induced

Study Officials

• Cansu DAL

  Muğla Sıtkı Koçman University

  PRINCIPAL INVESTIGATOR

• Meltem KOÇ

  Muğla Sıtkı Koçman University

  STUDY DIRECTOR

• Banu BAYAR

  Muğla Sıtkı Koçman University

  STUDY DIRECTOR

Central Study Contacts

Cansu DAL

CONTACT

5379773071; ptcansudal@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 18, 2023
• Study Start: October 16, 2023
• Primary Completion: December 8, 2023
• Study Completion: December 10, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Locations

TU (1)