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Esoteric Connective Tissue Therapy for chronic low back pain to reduce pain, and improve functionality and general well-being compared with physiotherapy: study protocol for a randomised controlled trial.
Trials. 2017 07 17; 18(1):328.T

Abstract

BACKGROUND

Low back pain causes more global disability than any other condition. Once the acute pain becomes chronic, about two-thirds of sufferers will not fully recover after 1-2 years. There is a paucity of effective treatments for non-specific, chronic low back pain. It has been noted that low back pain is associated with changes in the connective tissue in the affected area, and a very low-impact treatment, Esoteric Connective Tissue Therapy (ECTT), has been developed to restore flexibility in connective tissue. ECTT uses patterns of very small, circular movements, to the legs, arms, spine, sacrum and head, which anecdotally are effective in pain relief. In an unpublished single-arm phase I/II trial with chronic pain patients, ECTT showed a 56% reduction in pain after five treatments and 45% and 54% improvements at 6 months and 7-9 years of follow-up respectively.

METHODS

The aim of this randomised controlled trial is to compare ECTT with physiotherapy for reducing pain and improving physical function and physical and mental well-being in patients with chronic low back pain. The trial will be held at two hospitals in Vietnam. One hundred participants with chronic low back pain greater than or equal to 40/100 on the visual analogue scale will be recruited and randomised to either ECTT or physiotherapy. Four weekly treatments will be provided by two experienced ECTT practitioners (Treatment Group, 40 minutes each) and hospital-employed physiotherapy nurses (Control Group, 50 minutes). The primary outcomes will be changes in pain, physical function per the Quebec Pain Functionality Questionnaire and physical and mental well-being recorded by the Short Form Health Survey (SF-36), with mixed modelling used as the primary statistical tool because the data are longitudinal. Initial follow-up will be at either 4 or 8 months, with a second follow-up after 12 months.

DISCUSSION

The trial design has important strengths, because it is to be conducted in hospitals under medical supervision, because ECTT is to be compared with a standard therapy and because the assessor and analyst are to be blinded. The findings from this trial will provide evidence of the efficacy of ECTT for chronic low back pain compared with standard physiotherapy treatment.

TRIAL REGISTRATION

Australian New Zealand Clinical Trials Registry, ACTRN12616001196437 . Registered on 30 August 2016.

Authors+Show Affiliations

School of Public Health, University of Queensland, Herston Road, Herston, QLD, Australia. christoph.schnelle@uq.net.au.Total Health From Inside Out Pty Ltd, Brisbane and Gold Coast, Australia.Department of Surgery, Antrim Area Hospital, 45 Bush Rd, Antrim, BT41 2RL, UK. Queen's University Belfast, University Rd, Belfast, BT7 1NN, UK.Independent physiotherapist, practising in Goonellabah, Australia.The Rheumatology Centre, Sydney and Nowra, Australia.Independent psychologist, practising in Sunshine Coast, Australia.University of New South Wales, High Street, Kensington, NSW, Australia.School of Public Health, University of Queensland, Herston Road, Herston, QLD, Australia.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

28716108

Citation

Schnelle, Christoph, et al. "Esoteric Connective Tissue Therapy for Chronic Low Back Pain to Reduce Pain, and Improve Functionality and General Well-being Compared With Physiotherapy: Study Protocol for a Randomised Controlled Trial." Trials, vol. 18, no. 1, 2017, p. 328.
Schnelle C, Messerschmidt S, Minford EJ, et al. Esoteric Connective Tissue Therapy for chronic low back pain to reduce pain, and improve functionality and general well-being compared with physiotherapy: study protocol for a randomised controlled trial. Trials. 2017;18(1):328.
Schnelle, C., Messerschmidt, S., Minford, E. J., Greenaway-Twist, K., Szramka, M., Masiorski, M., Sheldrake, M., & Jones, M. (2017). Esoteric Connective Tissue Therapy for chronic low back pain to reduce pain, and improve functionality and general well-being compared with physiotherapy: study protocol for a randomised controlled trial. Trials, 18(1), 328. https://doi.org/10.1186/s13063-017-2055-8
Schnelle C, et al. Esoteric Connective Tissue Therapy for Chronic Low Back Pain to Reduce Pain, and Improve Functionality and General Well-being Compared With Physiotherapy: Study Protocol for a Randomised Controlled Trial. Trials. 2017 07 17;18(1):328. PubMed PMID: 28716108.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Esoteric Connective Tissue Therapy for chronic low back pain to reduce pain, and improve functionality and general well-being compared with physiotherapy: study protocol for a randomised controlled trial. AU - Schnelle,Christoph, AU - Messerschmidt,Steffen, AU - Minford,Eunice J, AU - Greenaway-Twist,Kate, AU - Szramka,Maxine, AU - Masiorski,Marianna, AU - Sheldrake,Michelle, AU - Jones,Mark, Y1 - 2017/07/17/ PY - 2016/09/22/received PY - 2017/06/08/accepted PY - 2017/7/19/entrez PY - 2017/7/19/pubmed PY - 2018/5/1/medline KW - Chronic low back pain KW - Connective tissue KW - Esoteric Connective Tissue Therapy KW - Low back pain KW - Physiotherapy KW - Randomised controlled trial SP - 328 EP - 328 JF - Trials JO - Trials VL - 18 IS - 1 N2 - BACKGROUND: Low back pain causes more global disability than any other condition. Once the acute pain becomes chronic, about two-thirds of sufferers will not fully recover after 1-2 years. There is a paucity of effective treatments for non-specific, chronic low back pain. It has been noted that low back pain is associated with changes in the connective tissue in the affected area, and a very low-impact treatment, Esoteric Connective Tissue Therapy (ECTT), has been developed to restore flexibility in connective tissue. ECTT uses patterns of very small, circular movements, to the legs, arms, spine, sacrum and head, which anecdotally are effective in pain relief. In an unpublished single-arm phase I/II trial with chronic pain patients, ECTT showed a 56% reduction in pain after five treatments and 45% and 54% improvements at 6 months and 7-9 years of follow-up respectively. METHODS: The aim of this randomised controlled trial is to compare ECTT with physiotherapy for reducing pain and improving physical function and physical and mental well-being in patients with chronic low back pain. The trial will be held at two hospitals in Vietnam. One hundred participants with chronic low back pain greater than or equal to 40/100 on the visual analogue scale will be recruited and randomised to either ECTT or physiotherapy. Four weekly treatments will be provided by two experienced ECTT practitioners (Treatment Group, 40 minutes each) and hospital-employed physiotherapy nurses (Control Group, 50 minutes). The primary outcomes will be changes in pain, physical function per the Quebec Pain Functionality Questionnaire and physical and mental well-being recorded by the Short Form Health Survey (SF-36), with mixed modelling used as the primary statistical tool because the data are longitudinal. Initial follow-up will be at either 4 or 8 months, with a second follow-up after 12 months. DISCUSSION: The trial design has important strengths, because it is to be conducted in hospitals under medical supervision, because ECTT is to be compared with a standard therapy and because the assessor and analyst are to be blinded. The findings from this trial will provide evidence of the efficacy of ECTT for chronic low back pain compared with standard physiotherapy treatment. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12616001196437 . Registered on 30 August 2016. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/28716108/Esoteric_Connective_Tissue_Therapy_for_chronic_low_back_pain_to_reduce_pain_and_improve_functionality_and_general_well_being_compared_with_physiotherapy:_study_protocol_for_a_randomised_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2055-8 DB - PRIME DP - Unbound Medicine ER -