CTRI/2026/01/102567 [Registered on: 30/01/2026] Trial Registered Prospectively
Last Modified On:
29/01/2026
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Other (Specify) [Physiotherapy with Yoga and Pilates]
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Combined Effects of Yoga and Pilates versus Conventional Exercises on Pain, Core Strength, fear of movement, and Disability in Patients with Non-Specific Low Back Pain for longer time: A Randomized Controlled Trial
Scientific Title of Study
Combined Effects of Yoga and Pilates versus Conventional Exercises on Pain, Core Strength, Kinesiophobia, and Disability in Patients with Chronic Non-Specific Low Back Pain: A Randomized Controlled Trial
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Nirav Vaghela
Designation
Principal and Professor
Affiliation
K.M. Patel Institute of Physiotherapy
Address
Shree Krishna Hospital, K.M. Patel Institute of Physiotherapy, OPD number- 152, Karamsad, Anand, Gujarat.
Anand GUJARAT 388325 India
Phone
9428647304
Fax
Email
niravpv@charutarhealth.org
Details of Contact Person Scientific Query
Name
Dr Bhavya Soni
Designation
MPT Student
Affiliation
K.M. Patel Institute of Physiotherapy
Address
Shree Krishna Hospital, K.M. Patel Institute of Physiotherapy, OPD number- 152, Karamsad, Anand, Gujarat.
Anand GUJARAT 388325 India
Phone
8866505004
Fax
Email
bhavyavsoni8@gmail.com
Details of Contact Person Public Query
Name
Dr Bhavya Soni
Designation
MPT Student
Affiliation
K.M. Patel Institute of Physiotherapy
Address
Shree Krishna Hospital, K.M. Patel Institute of Physiotherapy, OPD number- 152, Karamsad, Anand, Gujarat.
GUJARAT 388325 India
Phone
8866505004
Fax
Email
bhavyavsoni8@gmail.com
Source of Monetary or Material Support
Kinesiotherapy and Electrotherapy Unit of Physiotherapy Department, K.M. Patel Institute of Physiotherapy, Shree Krishna Hospital, Karamsad, Anand, Gujarat, India- 388325.
Primary Sponsor
Name
Nil
Address
NIL
Type of Sponsor
Other [NIL]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Nirav Vaghela
dept no 152 physiotherapy dept
Shree Krishna Hospital, K.M. Patel Institute of Physiotherapy, OPD number- 152, Karamsad, Anand, Gujarat. Anand GUJARAT
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Combined Yoga and Pilates
Baseline assessment and evaluation same as the Comparator group. The intervention will consist of supervised combined Yoga–Pilates exercises conducted five sessions per week, with each session lasting 45–60 minutes. Exercises will be performed in supine, prone, quadruped, and standing positions as appropriate. A physiotherapist will continuously supervise the sessions to ensure correct posture, proper technique, and participant safety.
Each session will begin with a 10-minute warm-up comprising pelvic tilts (9 repetitions with a 10-second hold), cat–cow stretches (9 repetitions), spinal articulation movements (9 repetitions), and diaphragmatic breathing for 3–5 minutes. This will be followed by a 30–35 minute core strengthening phase including the Hundred (5 repetitions, 20 seconds each), single-leg stretch (5 repetitions per leg, 20 seconds each), double-leg stretch (5 repetitions, 20 seconds each), plank variations (forearm, side, and dynamic; 3 repetitions with 20–30 second holds), Ardha or Paripurna Navasana (5 repetitions, 20 seconds each), Adho Mukha Svanasana (5 repetitions, 20 seconds each), Utkatasana (5 repetitions, 20 seconds each), Bird Dog (5 repetitions per side with a 20-second hold), and Setu Bandhasana (5 repetitions with a 20-second hold). The session will conclude with a 5–10 minute cool-down and relaxation phase consisting of Balasana (20–30 second hold), gentle supine spinal rotations with knees bent (5 repetitions per side), and Savasana with diaphragmatic breathing for 3–5 minutes. Participants will be provided with a 2-week home exercise program (5 days per week) that includes the same exercise protocol as described above. Adherence will be monitored using an exercise diary, and weekly follow-up calls by the physiotherapist will be conducted to provide guidance, address queries, and encourage compliance. Upon completion of a total of 15 sessions, comprising 5 supervised OPD sessions and 10 home-based sessions, a post-intervention assessment will be carried out to reassess all outcome measures.
Comparator Agent
Conventional Physiotherapy
Baseline assessment will be conducted before initiating the intervention and will include recording demographic details and outcome measures such as the Numeric Pain Rating Scale (NPRS), core strength using pressure biofeedback, the Tampa Scale for Kinesiophobia (TSK), and the Roland-Morris Disability Questionnaire (RMDQ), determing the participants’ pre-intervention status regarding pain intensity, core muscle strength, fear of movement, and functional disability in individuals with chronic non-specific low back pain. Supervised conventional exercise program, five sessions per week, with each session lasting 45–60 minutes, will be given. Exercises will be conducted in supine, prone, quadruped, and standing positions according to specific requirements. A physiotherapist will continuously supervise the sessions to ensure proper body alignment, correct movement execution, and participant safety through guidance, monitoring, and postural corrections. Each session will include a 5–10 minute warm-up consisting of pelvic tilts, cat-cow stretches, and gentle spinal rotations. This will be followed by a 30–35 minute core strengthening phase, including static back exercises, pelvic tilts, bridging, quadruped arm and leg raises, side-lying leg raises, and standing wall slides, each performed for 10–15 repetitions with 5-second holds where applicable. The session will conclude with a 5–10 minute cool-down phase comprising gentle spinal rotations, hamstring and hip flexor stretches held for 15–30 seconds, and relaxation breathing exercises for 3–5 minutes. Participants will be provided with a 2-week home exercise program (5 days per week) that includes the same exercise protocol as described above. Adherence will be monitored using an exercise diary and weekly follow-up calls by the physiotherapist to provide guidance, address queries, and encourage compliance. Upon completion of a total of 15 sessions, a post-intervention assessment of outcome measures will be carried out.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
The inclusion criteria for this study will include adults aged 18–60 years who are diagnosed with chronic non-specific low back pain, defined as pain persisting for at least 12 weeks, and who are willing to provide informed consent and comply with the prescribed exercise program. The inclusion criteria for this study will include adults aged 18–60 years who are diagnosed with chronic non-specific low back pain, defined as pain persisting for at least 12 weeks, and who are willing to provide informed consent and comply with the prescribed exercise program.
ExclusionCriteria
Details
The exclusion criteria will include individuals with specific spinal pathologies such as disc herniation with radiculopathy, spinal stenosis, osteoporosis, or neoplasm, those with a history of spinal surgery within the past year, participants presenting with neurological deficits or red-flag signs, pregnant women, and individuals with severe cardiorespiratory conditions or any other contraindications to exercise.
Method of Generating Random Sequence
Other
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Participant Blinded
Primary Outcome
Outcome
TimePoints
Numeric Pain Rating Scale (NPRS)
out come will be taken before intervention and after intervention which is of 3 week of exercise protocol so immediatly after protocol
Secondary Outcome
Outcome
TimePoints
Pressure Biofeedback for core strength evalutaion.
Outcome measures will be assessed at two time points: baseline, after participant enrollment and after intervention completion.
TAMPA scale for kinesiophobia to assess fear of movement and reinjury.
Outcome measures will be assessed at two time points: baseline, after participant enrollment and after intervention completion.
Ronald-Morris Disability Questionnaire (RMDQ) to assess the impact of pain on daily activity and functional mobility.
Outcome measures will be assessed at two time points: baseline, after participant enrollment and after intervention completion.
Target Sample Size
Total Sample Size="60" Sample Size from India="60" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
01/03/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="9" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Low back pain (LBP) is one of the most common musculoskeletal disorders and the leading cause of disability worldwide. The WHO highlights LBP as a major contributor to years lived with disability, and the GBD 2021 analysis confirms it remains the single leading cause of disability globally, with prevalence expected to rise due to ageing and sedentary lifestyles. LBP is classified by duration into acute (<6 weeks), sub-acute (6–12 weeks), and chronic (>12 weeks). Etiologically, it is categorised as specific (disc herniation, infection, fractures, tumors, inflammatory disorders) or non-specific, where no structural pathology is identified. Non-specific LBP accounts for nearly 85–90% of cases, making it the most common form. NSLBP presents as pain, stiffness, or discomfort between the lower ribs and gluteal folds, often associated with reduced mobility and functional limitations. Diagnosis is primarily clinical, focusing on ruling out red flags such as trauma, fever, neurological deficits, or malignancy. Imaging is generally discouraged unless red flags are present, as many findings are incidental. LBP imposes a major socioeconomic burden through healthcare costs, absenteeism, and productivity loss. In India, prevalence is high, and recurrence rates range from 24–80% within one year, highlighting its chronic and relapsing nature. Management includes pharmacological, surgical, and conservative approaches, but guidelines strongly recommend conservative care as the cornerstone. Conventional exercise programs (aerobic training, flexibility, core strengthening, motor control) reduce pain and disability but may not adequately address psychosocial factors like fear-avoidance and stress. Yoga, combining postures, breathing, and relaxation, has shown small to moderate improvements in pain, function, and psychological well-being. Pilates, emphasising deep trunk stabilisers and controlled movement, improves spinal stability, neuromuscular control, and functional outcomes. While yoga addresses biopsychosocial aspects and Pilates targets core stabilisation, studies on their combined application are limited. A yoga–Pilates fusion program may provide a more holistic intervention by integrating physical, psychological, and functional benefits for chronic NSLBP.
Need for the Study
Chronic non-specific low back pain (CNSLBP) is a highly prevalent, recurrent, and disabling condition that creates substantial personal as well as socioeconomic burden. Although exercise therapy is strongly recommended as a key component of management, conventional exercise programs often have limited effectiveness in addressing the psychosocial factors and neuromuscular impairments associated with chronicity. Yoga, by promoting relaxation and mental well-being, also contributes to activation and stabilization of important musculature. Pilates, on the other hand, is particularly effective in strengthening deep core muscles and enhancing neuromuscular control. The integration of yoga and Pilates may provide a synergistic and more holistic approach, potentially leading to better functional outcomes, greater confidence in movement, reduced fear of activity, and improved long-term adherence compared to conventional exercises alone. Since there is a lack of sufficient research evaluating the effectiveness of such a combined protocol, the present study is justified to investigate its efficacy in individuals with CNSLBP.
Aim
This study aims to evaluate the combined effect of yoga and Pilates compared with conventional exercises on pain, core strength, kinesiophobia, and disability in patients with chronic non-specific low back pain.