EFFECTS OF SPINAL MANIPULATION VERSUS ROUTINE PHYSICAL THERAPY ON THORACIC SPINAL PAIN;A RANDOMIZED CONTROLLED TRIAL

• To determine the effect of Spinal Manipulative Therapy on Thoracic Spinal Pain,ROM & QoL

A double blind randomized controlled trial.

This RCT will be conducted according to CONSORT guidelines . A parallel group RCT with 1:1 allocation ratio will be conducted at physical therapy department of Services Hospital Lahore. Patients will be asked to sign an informed consent. The assessor & patients will be blinded to allocation of treatment groups.

Inclusion: • Age between 40 and 60 years. • Mid line upper back pain, • Decreased thoracic range of motion Exclusion: • Severe spinal deformity • Any systemic disease e.g. cardiovascular or neurological etc. • Traumatic history and any other red flags of spinal pain

Experimental group will be managed with spinal manipulative therapy while the control group will be managed with routine physiotherapy and both the groups will receive ergonomic advice. The treatment will be given maximum for four weeks; three sessions per week. Then patients will be followed up at 8th and 12th week of treatment to check the consistency of effects.

 The Pain threshold will be measured with VAS  Quality of pain and the sensory dimensions will be assessed with McGill Pain Questionnaire  The subjective outcome of pain and disability will be obtained with the Oswestry Back Pain Disability Index  Objective measurement of ROM in the thoracic spine will be measured with the Goniometer.  Chest expansion will be measured by Measurement Tape  HR will be recorded by pulse oximeter and BP recording will be done by Digital sphygmomanometer.  QOL improvement will be judged by using QOL questionnaire .

Randomization: Subjects suitable for inclusion will be randomly allocated into two groups; group A/ Experimental group and group B/ control group using coin toss method and allocation sequence will be concealed through sealed envelopes. Concealment of allocation: Allocation concealment will be achieved with sequentially numbered, opaque, sealed, envelopes (SNOSE). SNOSE will be used according to guidelines of Doig and Simpson (25). An independent researcher with no clinical involvement in the trial will make the concealed envelopes. 100 Envelopes will be made. Half envelops will contain folded papers with Treatment A written on them and the remaining half will contain folded papers with Treatment B written on them. A carbon paper will be inserted in each envelop with carbon side facing the paper so the allocation sequence, patient name, date of birth of participant and other information can be transferred onto allocation paper inside the envelope. A piece of tin foil is also inserted into envelop so the treatment card cannot be read against light. Envelops will be sealed and signed by the maker. A unique randomized number will be allocated to these envelops and shuffled vigorously. Then the envelops will be arranged sequentially and handed over to another independent researcher. Assessor will pretest the participant and if eligible envelope will be allocated to subject. Therapist will record the information on the envelope and open it afterwards to maintain the concealment. Assessor will record the post treatment findings and another independent analyst will analyze the data. This allocation of concealment will ensure the unpredictability of treatment allocation by investigators and patients.

In these patients assessor will be blinded to allocation of treatment groups in this study. Patient will be blinded to treatment allocation as treatment will be given in separate rooms for each group. Therapist who is not blinded will not take the outcome measurements.