title: The immediate effect of traditional Malay massage on substance P, inflammatory mediators, pain scale and functional outcome among patients with low back pain: study protocol of a randomised controlled trial.
abstract: BACKGROUND
  The treatment of low back pain is very challenging due to the recurrent nature of the problem. It is believed that traditional Malay massage helps to relieve such back pain but there is a lack of scientific evidence to support both the practice of traditional Malay massage and the mechanism by which it exerts its effect. The aim of this study is to investigate the immediate effect of traditional Malay massage on the pain scale, substance P, inflammatory mediators, and functional outcomes among low back pain patients.
  
  
  METHODS
  A non-blinded, randomised controlled trial will be conducted. A total of sixty-six patients who fulfil the inclusion criteria will be recruited. The participants will be randomly allocated into intervention (traditional Malay massage) and control (relaxation position) groups. Blood and saliva samples will be collected before and immediately after intervention. All collected samples will be analysed. The primary outcomes are the changes in the level of substance P in both saliva and blood samples between both groups. The secondary outcomes include the levels of inflammatory mediators [i.e. TNF-α, IL-1β, IL-8, monocyte chemotactic protein-1, IL-6 and IL-10, and the soluble form of the intercellular adhesion molecule], the pain intensity as measured by a visual analogous scale and functional outcomes using the Roland-Morris Disability Questionnaire.
  
  
  CONCLUSIONS
  Massage is a type of physical therapy that has been proven to be potentially capable of reducing unpleasant pain sensations by a complex sensory response and chemical mediators such as substance P and various inflammatory mediators. Previous studies conducted using Thai, Swedish, or other forms of massage therapies, have showed inconsistent findings on substance P levels pre and post the interventions. Each massage genre varies in terms of massage and joint mobilization points, as well as the lumbar spinous process. Traditional Malay massage, known locally as "Urut Melayu", involves soft-tissue manipulation of the whole body applied using the hands and fingers. This massage technique combines both deep muscular tissue massage and spiritual rituals. This trial is expected to give rise to new knowledge underlying the mechanisms for pain and inflammation relief that are activated by traditional Malay massage.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials ACTRN12615000537550 .
authors.affiliation: Physiotherapy Department, Faculty of Health Sciences, Universiti Teknologi MARA (UiTM), Puncak Alam, Malaysia.
authors.forename: Nurhanisah
authors.initials: N
authors.lastname: Sejari
authors.affiliation: Physiotherapy Department, Faculty of Health Sciences, Universiti Teknologi MARA (UiTM), Puncak Alam, Malaysia.
authors.forename: Kamaria
authors.initials: K
authors.lastname: Kamaruddin
authors.affiliation: Faculty of Pharmacy, Universiti Teknologi MARA (UiTM), Bandar Puncak Alam, 42300, Selangor Darul Ehsan, Malaysia.|Collaborative Drug Discovery Research (CDDR) Group, Pharmaceutical and Life Sciences CoRe, Universiti Teknologi MARA (UiTM), Shah Alam, 40450, Selangor Darul Ehsan, Malaysia.
authors.forename: Kalavathy
authors.initials: K
authors.lastname: Ramasamy
authors.affiliation: Faculty of Pharmacy, Universiti Teknologi MARA (UiTM), Bandar Puncak Alam, 42300, Selangor Darul Ehsan, Malaysia.|Collaborative Drug Discovery Research (CDDR) Group, Pharmaceutical and Life Sciences CoRe, Universiti Teknologi MARA (UiTM), Shah Alam, 40450, Selangor Darul Ehsan, Malaysia.
authors.forename: Siong Meng
authors.initials: SM
authors.lastname: Lim
authors.affiliation: Faculty of Pharmacy, Universiti Teknologi MARA (UiTM), Bandar Puncak Alam, 42300, Selangor Darul Ehsan, Malaysia.|Collaborative Drug Discovery Research (CDDR) Group, Pharmaceutical and Life Sciences CoRe, Universiti Teknologi MARA (UiTM), Shah Alam, 40450, Selangor Darul Ehsan, Malaysia.
authors.forename: Chin Fen
authors.initials: CF
authors.lastname: Neoh
authors.affiliation: Faculty of Pharmacy, Universiti Teknologi MARA (UiTM), Bandar Puncak Alam, 42300, Selangor Darul Ehsan, Malaysia. ming.long@bath.edu.|Brain Degeneration and Therapeutics Group, Pharmaceutical and Life Sciences CoRe, Universiti Teknologi MARA (UiTM), Shah Alam, 40450, Selangor Darul Ehsan, Malaysia. ming.long@bath.edu.
authors.forename: Long Chiau
authors.initials: LC
authors.lastname: Ming
mesh_terms: D002985:Clinical Protocols; D006801:Humans; D018836:Inflammation Mediators / Q000378:metabolism*; D017116:Low Back Pain / Q000628:therapy*; D008405:Massage / Q000379:methods; D017063:Outcome Assessment, Health Care; D010147:Pain Measurement; D018579:Patient Selection; D013373:Substance P / Q000378:metabolism*
chemical_list: D018836:Inflammation Mediators; D013373:Substance P