Effects of Connective Tissue Massage and Classical Massage

NCT04211701 | Unknown

• 1 other identifier: ETK00-2019-0177
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

As a randomized study, this study aimed to investigate the effects of classical massage and connective tissue massage on pain, flexibility, disability, quality of life and autonomic responses in patients with chronic mechanical low back pain. The primary evaluation parameter of the study is autonomic function and the secondary evaluation parameter is pain. The participants will be treated accompanied with same physiotherapist along four weeks and five days in a week. A six-week follow-up will be performed to see how long the effect of the treatment continues.

Conditions

Body Temperature

Keywords

Connective Tissue; Massage; Peripheral Nervous System

Outcome Measures

Primary Outcomes (4)

• Changes in autonomic function (pulse) compared with baseline and last measurement

  Pulse will be measured with pulse oximeter (pulse/min).

  Measurements will be made at baseline and 4th week (last assessment). It takes about one minute.

• Changes in autonomic function (blood pressure) compared with baseline and last measurement

  Blood pressure will be measured with manual sphygmomanometer (mmHg).

  Measurements will be made at baseline and 4th week (last assessment). It takes about two minutes

• Changes in autonomic function (temperature) compared with baseline and last measurement

  Local temperature and peripheral temperature measurements will be made with laser-marked heat meter (°C).

  Measurements will be made at baseline and 4th week (last assessment). It takes about five minutes

• Changes in low back pain compared with baseline and last measurement

  Low back pain will be measured with using Visual Analog Scale (cm).

  Measurements will be made at baseline and 4th week (last assessment). It takes about one minute.

Secondary Outcomes (12)

• Changes in disability compared to baseline with baseline and last measurement

  Measurements will be made at baseline and 4th week (last assessment). It takes about three minutes.

• Changes in quality of life compared to baseline with baseline and last measurement

  Measurements will be made at baseline and 4th week (last assessment). It takes about three minutes.

• Changes in flexibility (lumbar lateral flexion test) compared to baseline with baseline and last measurement

  Measurements will be made at baseline and 4th week (last assessment). It takes about five minutes.

• Changes in flexibility (sit and reach) compared to baseline with baseline and last measurement

  Measurements will be made at baseline and 4th week (last assessment). It takes about two minutes.

• Changes in autonomic function (pulse) at six weeks after the end of the treatment

  Measurements will be made at six weeks after the end of the treatment. It takes about one minute.

Study Arms (2)

Connective Tissue Massage

EXPERIMENTAL

Connective tissue massage will be applied to the lumbo-sacral region, lower thoracic, scapular and interscapular regions, respectively. The treatment will be administered for four weeks, five days a week.

Procedure: Connective Tissue Massage

Classical Massage

EXPERIMENTAL

Classic massage will be applied to the lower back and upper back, respectively, while the patient is lying in the prone position. The treatment will be administered for four weeks, five days a week.

Procedure: Classical Massage

Interventions

Connective Tissue Massage PROCEDURE

Connective tissue massage (CTM) will be applied to the lumbo-sacral region, lower thoracic, scapular and interscapular regions. Three to five pulling will be applied during massage. The treatment will be administered for four weeks, five days a week.

Connective Tissue Massage

Classical Massage PROCEDURE

Classic massage (CM) will be applied to the lower back and upper back while the patient is lying in the prone position. Three stroking will be applied during massage.The treatment will be administered for four weeks, five days a week.

Classical Massage

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being between 20-60 years of age
• Low back pain for more than 12 weeks
• Lack of neurological problems caused by lumbar region
• Not to be included in physiotherapy and rehabilitation program in the last 6 months

You may not qualify if:

• Having ankylosing spondylitis
• Pain and / or numbness in the hip and lower extremities
• Previous trauma or surgery in lumbar region
• Presence of congenital malalignment in the vertebral column
• Malignancy
• Lower limb inequality over one cm
• Pregnancy
• Blood pressure difference of more than 10 mmHg between two arms

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Eastern Mediterranean University

Mersin, Famagusta, 33010, Turkey (Türkiye)

RECRUITING

Related Publications (18)

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  PMID: 21982256 BACKGROUND

• Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.

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• Oksuz E. Prevalence, risk factors, and preference-based health states of low back pain in a Turkish population. Spine (Phila Pa 1976). 2006 Dec 1;31(25):E968-72. doi: 10.1097/01.brs.0000247787.25382.3c.

  PMID: 17139213 BACKGROUND

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  PMID: 19561560 BACKGROUND

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  PMID: 16290894 BACKGROUND

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  PMID: 16919887 BACKGROUND

• Kavlak E, Buker N, Altug F, Kitis A. Investigation of the effects of connective tissue mobilisation on quality of life and emotional status in healthy subjects. Afr J Tradit Complement Altern Med. 2014 Apr 3;11(3):160-5. doi: 10.4314/ajtcam.v11i3.23. eCollection 2014.

  PMID: 25371578 BACKGROUND

• Yüksel İ, Baltacıoğlu S, Akbayrak T. Konnektif Doku Masajı. In: Yüksel İ, editor. Masaj Teknikleri. 4th ed. Ankara: Hipokrat Kitabevi & Pelikan Kitabevi; 2016. p. 283-354

  BACKGROUND

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  PMID: 25108749 BACKGROUND

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  PMID: 21875520 BACKGROUND

• Toprak Celenay S, Anaforoglu Kulunkoglu B, Yasa ME, Sahbaz Pirincci C, Un Yildirim N, Kucuksahin O, Ugurlu FG, Akkus S. A comparison of the effects of exercises plus connective tissue massage to exercises alone in women with fibromyalgia syndrome: a randomized controlled trial. Rheumatol Int. 2017 Nov;37(11):1799-1806. doi: 10.1007/s00296-017-3805-3. Epub 2017 Aug 24.

  PMID: 28840379 BACKGROUND

• Brattberg G. Connective tissue massage in the treatment of fibromyalgia. Eur J Pain. 1999 Jun;3(3):235-244. doi: 10.1053/eujp.1999.0123.

  PMID: 10700351 BACKGROUND

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  PMID: 15129077 BACKGROUND

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  BACKGROUND

• Natour J, Cazotti Lde A, Ribeiro LH, Baptista AS, Jones A. Pilates improves pain, function and quality of life in patients with chronic low back pain: a randomized controlled trial. Clin Rehabil. 2015 Jan;29(1):59-68. doi: 10.1177/0269215514538981. Epub 2014 Jun 25.

  PMID: 24965957 BACKGROUND

• Vischer AS, Burkard T. Principles of Blood Pressure Measurement - Current Techniques, Office vs Ambulatory Blood Pressure Measurement. Adv Exp Med Biol. 2017;956:85-96. doi: 10.1007/5584_2016_49.

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• Gatt A, Formosa C, Cassar K, Camilleri KP, De Raffaele C, Mizzi A, Azzopardi C, Mizzi S, Falzon O, Cristina S, Chockalingam N. Thermographic patterns of the upper and lower limbs: baseline data. Int J Vasc Med. 2015;2015:831369. doi: 10.1155/2015/831369. Epub 2015 Jan 13.

  PMID: 25648145 BACKGROUND

Study Officials

• Göktuğ Er

  MPT

  PRINCIPAL INVESTIGATOR

• İnci Yüksel

  DPT

  STUDY DIRECTOR

Central Study Contacts

Göktuğ Er, MPT

CONTACT

+905428721546; goktugenator@gmail.com

İnci Yüksel, DPT

CONTACT

+905322537388; yukselinci@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 26, 2019
• Study Start: October 22, 2019
• Primary Completion: December 24, 2019
• Study Completion: June 15, 2020
• Last Updated: December 26, 2019

Record last verified: 2019-12

Locations

TU (1)