Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06030128
Other study ID # 20230506002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2023
Est. completion date September 1, 2025

Study information

Verified date February 2024
Source The Hong Kong Polytechnic University
Contact Patrick Kwong, PhD
Phone 852-62353459
Email whkwong@polyu.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objectives: To develop an exercise program for older adults with low back pain. And,to develop a clinical prediction rule that could identify a subgroup of people with NSLBP Participants: 150 people aged between 40 to 80 with non-specific low back pain (NSLBP) for more than 6 months and is able to ambulate independently will be invited to join the study. People who had 1) previous spinal surgery; 2) LBP attributable to current pregnancy; 3) acute fracture, recent fall, tumour, or bone infection; and 4) experience of practising core-stability exercises in the past 6 months will be excluded. Study details will be explained to participants and written consent will be obtained prior the study. 75 participants will be randomized into the intervention group. Another 75 participants will be randomized into the waiting list control group. Assessment Participants will undergo two comprehensive assessments before and after the training, which includes: Surface electromyogram (EMG) on the lumbar spine and abdominal muscle, Inertial measurement unit (IMU) sensor for trunk movement, clinical assessment including. Prone instability test. Subjective assessments: Visual analogue scale score for pain, The Oswestry Low Back Pain Disability Questionnaire and Roland-Morris Disability Questionnaire. Intervention - 16 session structured exercise program All participants will undergo a 16 session exercise program for 2 months. Each session will last for 60minutes. The exercise program will be arranged in a group format with class size ranging from 6 - 8 per class Subjects will be divided into experimental and control groups. Participants in the control group will not receive exercise training at first but were evaluated at the same time as participants in the experimental group. The participant in the control group completed the exercise training after the post-assessment.


Description:

People with non-specific low back pain (NSLBP) demonstrate diversified clinical signs and symptoms. It is because the cause of NSLBP is multifaceted. Due to the varied pathophysiology and clinical behavior, the 'one-suit-all' approach of physiotherapy treatment prescription for people with NSLBP is usually less effective in reducing pain and improving daily function. Research on identifying subgroups of patients with NSLBP who would benefit from physiotherapy interventions could provide clinicians evidence-based guidelines and enhance the cost-effectiveness of health care service. Earlier research showed that people with NSLBP demonstrated a delay in core muscle activation and general wasting of the trunk and core muscle. These pathological changes support the use of core stability training (e.g., Pilates exercise) to manage people with NSLBP. However, effectiveness of core stability training have not been studied extensively in older adults.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date September 1, 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria: - 1)people aged between 40 to 80 with non-specific low back pain (NSLBP) for more than 6 months ;2)people is able to ambulate independently Exclusion Criteria: - 1) previous spinal surgery; 2) LBP attributable to current pregnancy; 3) acute fracture, recent fall, tumour, or bone infection; and 4) experience of practising core-stability exercises in the past 6 months

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
core stabilization exercise
All participants will undergo a 16 session exercise program for 2 months. Each session will last for 60minutes. The exercise program will be arranged in a group format with class size ranging from 6-8 per class. Subjects will be divided into experimental and control groups.

Locations

Country Name City State
Hong Kong The Hong Kong Polytechnic University Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

References & Publications (17)

Aladro-Gonzalvo AR, Araya-Vargas GA, Machado-Diaz M, Salazar-Rojas W. Pilates-based exercise for persistent, non-specific low back pain and associated functional disability: a meta-analysis with meta-regression. J Bodyw Mov Ther. 2013 Jan;17(1):125-36. doi: 10.1016/j.jbmt.2012.08.003. Epub 2012 Sep 16. — View Citation

Arendt-Nielsen L, Graven-Nielsen T, Svarrer H, Svensson P. The influence of low back pain on muscle activity and coordination during gait: a clinical and experimental study. Pain. 1996 Feb;64(2):231-240. doi: 10.1016/0304-3959(95)00115-8. — View Citation

Assendelft WJ, Morton SC, Yu EI, Suttorp MJ, Shekelle PG. Spinal manipulative therapy for low back pain. A meta-analysis of effectiveness relative to other therapies. Ann Intern Med. 2003 Jun 3;138(11):871-81. doi: 10.7326/0003-4819-138-11-200306030-00008. — View Citation

Cooper RG, St Clair Forbes W, Jayson MI. Radiographic demonstration of paraspinal muscle wasting in patients with chronic low back pain. Br J Rheumatol. 1992 Jun;31(6):389-94. doi: 10.1093/rheumatology/31.6.389. — View Citation

Danneels LA, Vanderstraeten GG, Cambier DC, Witvrouw EE, De Cuyper HJ. CT imaging of trunk muscles in chronic low back pain patients and healthy control subjects. Eur Spine J. 2000 Aug;9(4):266-72. doi: 10.1007/s005860000190. — View Citation

Fritz JM, Lindsay W, Matheson JW, Brennan GP, Hunter SJ, Moffit SD, Swalberg A, Rodriquez B. Is there a subgroup of patients with low back pain likely to benefit from mechanical traction? Results of a randomized clinical trial and subgrouping analysis. Spine (Phila Pa 1976). 2007 Dec 15;32(26):E793-800. doi: 10.1097/BRS.0b013e31815d001a. — View Citation

Hayden JA, van Tulder MW, Malmivaara AV, Koes BW. Meta-analysis: exercise therapy for nonspecific low back pain. Ann Intern Med. 2005 May 3;142(9):765-75. doi: 10.7326/0003-4819-142-9-200505030-00013. — View Citation

Hicks GE, Fritz JM, Delitto A, McGill SM. Preliminary development of a clinical prediction rule for determining which patients with low back pain will respond to a stabilization exercise program. Arch Phys Med Rehabil. 2005 Sep;86(9):1753-62. doi: 10.1016/j.apmr.2005.03.033. — View Citation

Kato S, Murakami H, Demura S, Yoshioka K, Shinmura K, Yokogawa N, Igarashi T, Yonezawa N, Shimizu T, Tsuchiya H. Abdominal trunk muscle weakness and its association with chronic low back pain and risk of falling in older women. BMC Musculoskelet Disord. 2019 Jun 3;20(1):273. doi: 10.1186/s12891-019-2655-4. — View Citation

Lamoth CJ, Meijer OG, Daffertshofer A, Wuisman PI, Beek PJ. Effects of chronic low back pain on trunk coordination and back muscle activity during walking: changes in motor control. Eur Spine J. 2006 Jan;15(1):23-40. doi: 10.1007/s00586-004-0825-y. Epub 2005 Apr 29. — View Citation

Lee JH, Hoshino Y, Nakamura K, Kariya Y, Saita K, Ito K. Trunk muscle weakness as a risk factor for low back pain. A 5-year prospective study. Spine (Phila Pa 1976). 1999 Jan 1;24(1):54-7. doi: 10.1097/00007632-199901010-00013. — View Citation

Lue YJ, Hsieh CL, Huang MH, Lin GT, Lu YM. Development of a Chinese version of the Oswestry Disability Index version 2.1. Spine (Phila Pa 1976). 2008 Oct 1;33(21):2354-60. doi: 10.1097/BRS.0b013e31818018d8. — View Citation

Luomajoki H, Kool J, de Bruin ED, Airaksinen O. Reliability of movement control tests in the lumbar spine. BMC Musculoskelet Disord. 2007 Sep 12;8:90. doi: 10.1186/1471-2474-8-90. — View Citation

Nakamura M, Nishiwaki Y, Sumitani M, Ushida T, Yamashita T, Konno S, Taguchi T, Toyama Y. Investigation of chronic musculoskeletal pain (third report): with special reference to the importance of neuropathic pain and psychogenic pain. J Orthop Sci. 2014 Jul;19(4):667-75. doi: 10.1007/s00776-014-0567-6. Epub 2014 Apr 16. — View Citation

Ravenna MM, Hoffman SL, Van Dillen LR. Low interrater reliability of examiners performing the prone instability test: a clinical test for lumbar shear instability. Arch Phys Med Rehabil. 2011 Jun;92(6):913-9. doi: 10.1016/j.apmr.2010.12.042. — View Citation

Roussel NA, Nijs J, Meeus M, Mylius V, Fayt C, Oostendorp R. Central sensitization and altered central pain processing in chronic low back pain: fact or myth? Clin J Pain. 2013 Jul;29(7):625-38. doi: 10.1097/AJP.0b013e31826f9a71. — View Citation

Walter BA, Mageswaran P, Mo X, Boulter DJ, Mashaly H, Nguyen XV, Prevedello LM, Thoman W, Raterman BD, Kalra P, Mendel E, Marras WS, Kolipaka A. MR Elastography-derived Stiffness: A Biomarker for Intervertebral Disc Degeneration. Radiology. 2017 Oct;285(1):167-175. doi: 10.1148/radiol.2017162287. Epub 2017 May 4. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary The Oswestry Low Back Pain Disability Questionnaire is a widely used questionnaire designed to assess the level of disability and functional impairment in individuals with lower back pain. The questionnaire consists of 10 sections, each focusing on a different aspect of daily living that might be affected by back pain, such as personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and traveling.
Each section is scored on a scale of 0 to 5, with higher scores indicating greater disability. The scores for all sections are then summed and converted to a percentage, which can range from 0% (no disability) to 100% (maximum disability).
pre-intervention session (T1)
Primary The Oswestry Low Back Pain Disability Questionnaire is a widely used questionnaire designed to assess the level of disability and functional impairment in individuals with lower back pain. The questionnaire consists of 10 sections, each focusing on a different aspect of daily living that might be affected by back pain, such as personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and traveling.
Each section is scored on a scale of 0 to 5, with higher scores indicating greater disability. The scores for all sections are then summed and converted to a percentage, which can range from 0% (no disability) to 100% (maximum disability).
post-intervention (8 weeks after start of intervention;T2)
Secondary Visual analogue scale (VAS) score for pain The Visual Analogue Scale (VAS) is a tool commonly used to measure a person's pain intensity. The scale typically consists of a 10cm horizontal line. Anchored by two verbal descriptors, one for each symptom extreme. For pain intensity, the scale is most often anchored by "No Pain" at one end and "Worst Imaginable Pain" at the other.
Patients are asked to mark a point along the line that represents their current level of pain.
pre-intervention session (T1)
Secondary Visual analogue scale (VAS) score for pain The Visual Analogue Scale (VAS) is a tool commonly used to measure a person's pain intensity. The scale typically consists of a 10cm horizontal line. Anchored by two verbal descriptors, one for each symptom extreme. For pain intensity, the scale is most often anchored by "No Pain" at one end and "Worst Imaginable Pain" at the other.
Patients are asked to mark a point along the line that represents their current level of pain.
post-intervention (8 weeks after start of intervention;T2)
Secondary Fear-Avoidance Belief Questionnaire Participants finish the questionnaire with the help of investigators to assess how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability.
The scale score range from 0 - 96, a higher score indicates a higher level of fear avoidance beliefs.
pre-intervention session (T1)
Secondary Fear-Avoidance Belief Questionnaire Participants finish the questionnaire with the help of investigators to assess how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability.
The scale score range from 0 - 96, a higher score indicates a higher level of fear avoidance beliefs.
post-intervention (8 weeks after start of intervention;T2)
Secondary Surface EMG EMG-sensors attached to the skin overlying the erector spinae at the T4 vertebrae (approximately 2-3 cm from the midline of the back) on both sides. pre-intervention session (T1)
Secondary Surface EMG EMG-sensors attached to the skin overlying the erector spinae at the T4 vertebrae (approximately 2-3 cm from the midline of the back) on both sides. post-intervention (8 weeks after start of intervention;T2)
Secondary IMU-sensor IMU-sensors attached to the skin overlying the erector spinae at the T3 and L1 vertebrae(approximately 3-4 cm from the midline of the back), Pelvis(S2) and femur. IMU-sensors were positioned unilaterally on the right side. pre-intervention session (T1)
Secondary IMU-sensor IMU-sensors attached to the skin overlying the erector spinae at the T3 and L1 vertebrae(approximately 3-4 cm from the midline of the back), Pelvis(S2) and femur. IMU-sensors were positioned unilaterally on the right side. post-intervention (8 weeks after start of intervention;T2)
Secondary Prone instability test Participants will assume a face-down position on a bench, allowing their legs to dangle off the edge so that their feet touch the ground. Manual pressure will then be applied on various lumbar spine segments to induce pain. If pain occurs, participants then raise their legs off the ground before the application of back-to-front pressure is repeated. A reduction in pain when lifting the legs indicates the ability to actively stabilize the spine, signifying a positive test result. In such cases, a stability-focused exercise regimen would be appropriate for the individual. pre-intervention session (T1)
Secondary Prone instability test Participants will assume a face-down position on a bench, allowing their legs to dangle off the edge so that their feet touch the ground. Manual pressure will then be applied on various lumbar spine segments to induce pain. If pain occurs, participants then raise their legs off the ground before the application of back-to-front pressure is repeated. A reduction in pain when lifting the legs indicates the ability to actively stabilize the spine, signifying a positive test result. In such cases, a stability-focused exercise regimen would be appropriate for the individual. post-intervention (8 weeks after start of intervention;T2)
Secondary straight leg raise (SLR) The Straight Leg Raise (SLR) test is a commonly used diagnostic procedure to evaluate for the presence of lumbar radiculopathy, often caused by a herniated disc. During the test, the patient lies flat on their back on an examination table. The examiner then lifts one of the patient's straightened legs by the ankle, keeping the knee extended. pre-intervention session (T1)
Secondary straight leg raise (SLR) The Straight Leg Raise (SLR) test is a commonly used diagnostic procedure to evaluate for the presence of lumbar radiculopathy, often caused by a herniated disc. During the test, the patient lies flat on their back on an examination table. The examiner then lifts one of the patient's straightened legs by the ankle, keeping the knee extended post-intervention (8 weeks after start of intervention;T2)
Secondary internal rotation range of motion When the knee is in a position of flexion between 30 and 90 degrees, there are approximately 45 degrees external and 25 degrees internal rotation. Rotatory motion decreases with further extension and, at 5 degrees of flexion, the knee has 23 degrees external and 10 degrees internal rotation. pre-intervention session (T1)
Secondary internal rotation range of motion When the knee is in a position of flexion between 30 and 90 degrees, there are approximately 45 degrees external and 25 degrees internal rotation. Rotatory motion decreases with further extension and, at 5 degrees of flexion, the knee has 23 degrees external and 10 degrees internal rotation. post-intervention (8 weeks after start of intervention;T2)
Secondary FABER test The FABER test is used to identify the presence of hip pathology by attempting to reproduce pain in the hip, lumbar spine or sacroiliac region. The test is a passive screening tool for musculoskeletal pathologies, such as hip, lumbar spine, or sacroiliac joint dysfunction, or an iliopsoas spasm. pre-intervention session (T1)
Secondary FABER test The FABER test is used to identify the presence of hip pathology by attempting to reproduce pain in the hip, lumbar spine or sacroiliac region. The test is a passive screening tool for musculoskeletal pathologies, such as hip, lumbar spine, or sacroiliac joint dysfunction, or an iliopsoas spasm. post-intervention (8 weeks after start of intervention;T2)
See also
  Status Clinical Trial Phase
Recruiting NCT05963451 - Brain, Psychological and Epigenetic Determinants for Optimizing the Treatment of Chronic Low Back Pain
Completed NCT04283370 - A Study Protocol Comparing a Home Rehabilitation Program Versus e-Health Program in Low Back Pain N/A
Completed NCT04824547 - Evaluation of Long-Term Continuity of Exercises in Low Back Pain Individuals N/A
Completed NCT04046419 - In Turkish Version "Health Care Providers and Impairment Relationship Scale (HC-PAIRS)"
Completed NCT04399772 - COgNitive FuncTional Therapy+ for Chronic Low Back paIn N/A
Recruiting NCT05780021 - Motivational Support Program in Chronic Low Back Pain After Multidisciplinary Functional Rehabilitation N/A
Completed NCT04555278 - Combining Non-invasive Brain Stimulation and Exercise to Treat Low Back Pain N/A
Completed NCT04530071 - Evaluation of Safety, Tolerability, and Efficacy of CordSTEM-DD in Patients With Chronic Low Back Pain Phase 1/Phase 2
Not yet recruiting NCT06080464 - Clinician Satisfaction With the VERABANDâ„¢ N/A
Not yet recruiting NCT06347328 - The Benefits of Posterior Joint Infiltration in Chronic Low Back Pain N/A
Not yet recruiting NCT04940715 - Efficacy of Passive Joint Mobilization vs Mobilization With Movement on Pain Processing in Patients With Chronic Low Back Pain N/A
Recruiting NCT04683718 - A First in Human Feasibility Study to Evaluate the Safety and Effectiveness of the BIOTRONIK Prospera SCS System With HomeStream Remote Management N/A
Recruiting NCT05724160 - Using Non-Weightbearing Stationary Elliptical Machines for Patients With Chronic Low Back Pain N/A
Recruiting NCT05846087 - Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia N/A
Active, not recruiting NCT05396014 - The BEST Trial: Biomarkers for Evaluating Spine Treatments Phase 4
Active, not recruiting NCT06140862 - Ankle Spine Syndrome "RAFFET Syndrome II N/A
Completed NCT05512338 - Motivation and Adherence to Exercise Recommendations N/A
Recruiting NCT05021146 - Essential Oil for Chronic Low Back Pain N/A
Completed NCT05120921 - Osteopathic Single CAse Research for Patients With Chronic Low Back Pain N/A
Completed NCT06423755 - Swimming Versus Standard Physiotherapy Care as Rehabilitation Modalities for Persistent Low Back Pain: Feasibility Study N/A