Chronic Low-back PainNCT05449262
Time Course Effects of Functional Resistance Training on Fitness and Quality of Life Chronic Low Back Pain Patients
A study testing functional resistance training GROUP A and functional resistance training GROUP B in people with Chronic Low-back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Low back pain is categorized according to its duration as acute (<6 weeks), sub-acute (6 weeks - 12 weeks) and chronic (>12 weeks). Low back pain can be either specific or non-specific. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- functional resistance training GROUP A and functional resistance training GROUP B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Apr 2022to 5 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient having low back pain as a primary complaint, without associated leg pain;
- Chronic pain (>= 3 months, >= 3 days/week)
- non- specific (soft tissue in origin)
- Patient having no history of formal exercise training.
- Learning proper technique under expert supervision
- Postural stability (static/dynamic)
Who cannot join
- Receiving concurrent treatments from another practitioner for LBP
- Congenital deformities of spine
- Neurological conditions (neuropathy, radiculopathy)
- Musculoskeletal conditions (fractures, atrophy, weakness)
- Cardiovascular, Nephrological conditions
- Contraindications to exercise
- Involved in workers' compensation claims;
- Medications other than analgesics and NSAIDS
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Railway General Hospital
Rawalpindi, Punjab Province, 46000
About this study
Official title: Time Course Effects of Functional Resistance Training on Fitness and Quality of Life in Patients With Nonspecific Chronic Low-back Pain
Low back pain is categorized according to its duration as acute (<6 weeks), sub-acute (6 weeks - 12 weeks) and chronic (>12 weeks). Low back pain can be either specific or non-specific. Specific low back pain is because of specific spinal pathologies including; Malignancy, Infection, Osteoporotic Collapse, Fracture, Ankylosing Spondylitis or other inflammatory disorders and Cauda equina compression. About 19 in 20 cases of acute (sudden onset) low back pain are classed as 'non-specific' It is called 'non-specific' because it is usually not clear what is actually causing the pain or there is no specific problem or disease that can be identified as to the cause of the pain.Functional Resistance Training (FRT) involves multiplanar and multi joint resistance exercises that simulate movement patterns from everyday life and sport Functional training exercises tend to focus more on the coordination, technique, posture, and core engagement instead of on training loads.
Read the detailed description
The lower back is also called the 'lumbosacral area' of the back. It is the part of the back between the bottom of the ribs and the top of the legs and is made up of the spine bones (vertebrae), discs, nerves, muscles and ligaments. Pain in this region is called low back pain. (1) Low back pain is categorized according to its duration as acute (<6 weeks), sub-acute (6 weeks - 12 weeks) and chronic (>12 weeks). About 19 in 20 cases of acute (sudden onset) low back pain are classed as 'non-specific' It is called 'non-specific' because it is usually not clear what is actually causing the pain or there is no specific problem or disease that can be identified as to the cause of the pain. It is said that cause may be a sprain (an over-stretch) of a ligament or muscle, minor problem with the disc between two vertebrae, or a minor problem with a small 'facet' joint between two vertebrae. It is not possible to identify these causes of the pain by tests. Therefore, it is usually impossible to say exactly where the pain is coming from, or exactly what is causing the pain. Sometimes a pain may develop immediately after lifting something heavy, or after an awkward twisting movement. Sometimes it can develop for no apparent reason. Some people just wake up one day with low back pain. Typically the pain is in one area of the lower back, but sometimes it spreads to one or both buttocks or thighs. Non-specific low back pain is 'mechanical' in the sense that it varies with posture or activity. In a small number of cases the pain persists for several months or longer. This is called chronic back pain. There is no test that can prove or confirm non-specific low back pain.
Non-specific low back pain is classed as chronic (persistent) if it lasts longer than six weeks. In some people it lasts for months, or even years. Symptoms may be constant. Non-specific low back pain affects people of all ages and is a leading contributor to disease burden worldwide.
The ACSM defines functional RT (FRT) as activities involving multiple muscle, joint, and planar activities that are closely related to activities of daily living, combining upper and lower body movements to use more of the body in each movement. Few studies have examined FRT, though initial results suggest that FRT is associated with higher caloric expenditure and similar muscular strength, endurance, and gains in flexibility compared with a TRT program.
Functional training is becoming increasingly popular within the fitness industry and has been considered to be a better alternative than traditional resistance training for improving various measures of muscular fitness including strength, endurance, coordination and balance. The verb form of the word "function" pertains to the performance of an action, work or activity. Thus, exercise training programs that are deemed to be "functional" should be designed to mimic tasks or activities that occur in a person's daily life to make training adaptations more transferable. Engaging in regular RT provides physical, physiological and psychological health benefits while providing additional bone health benefits. Although RT has greatly increased in popularity, other types of training aside from traditional RT (TRT) have yet to be examined. One such type of training, ''functional fitness,'' is defined by the ACSM as the use of strength training to improve balance and ease of living, and was in the top 10 fitness trends in 2018.
Functional Resistance Training (FRT) involves multiplanar and multi joint resistance exercises that simulate movement patterns from everyday life and sport Functional training exercises tend to focus more on the coordination, technique, posture, and core engagement instead of on training loads. The goal of FRT is not hypertrophy but to promote a potential motor problem in order to train dynamic stabilization. Appropriate functional exercises are those in which the lumbo-pelvic region remains aligned within the neutral zone by co-contraction of the muscles of the trunk, while other demands executed with the extremities are simultaneously and successfully fulfilled. This method of training usually includes: a) spinal stabilization exercises; b) balance and proprioceptive exercises; c) flexibility exercises; d) resistance training exercises.
Functional RT may be more feasible and accessible due to the minimal equipment needed and the flexibility to be performed in and out of a typical gym setting.
- Conditions
- Chronic Low-back Pain
- Being tested
- functional resistance training GROUP A, functional resistance training GROUP B
- Keywords
- Pain, disability, strength, quality of life, functional resistance training
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional resistance training GROUP AOther
Session of 45-60 min. Warm up prior to training Warm up 6-7 min of mild cardiovascular exercise followed by 3-4 min stretching
Cool down post training A cool-down of 1 min of mild cardiovascular exercise followed by 4 min of stretching
functional resistance training GROUP BOther
Session of 45-60 min Warm up prior to training Warm up 6-7 min of mild cardiovascular exercise followed by 3-4 min stretching
Cool down post training A cool-down of 1 min of mild cardiovascular exercise followed by 4 min of stretching
| Study group | Role | What they receive |
|---|---|---|
| functional resistance training GROUP A | Experimental | Session of 45-60 min starting with Warm Up Exercise and stretching prior to therapy and cool-down and stretching after the training sessions Receives: Other: functional resistance training GROUP A |
| functional resistance training GROUP B | Experimental | Session of 45-60 min starting with Warm Up Exercise and stretching prior to therapy and cool-down and stretching after the training sessions Receives: Other: functional resistance training GROUP B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)for pain:
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. it is scientifically evident that VAS is a reliable and valid scale in aged more than 18 years. In many studies it is proved that VAS is a reliable scale but for validity it showed moderate to strong correlation for pain measurement. assessment to be done at base line after 6 weeks and after detraining of 6 weeks
Measured: 6 weeks
Visual analogue scale (VAS)for pain:
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. it is scientifically evident that VAS is a reliable and valid scale in aged more than 18 years. In many studies it is proved that VAS is a reliable scale but for validity it showed moderate to strong correlation for pain measurement. assessment to be done at base line after 12 weeks and after detraining of 12 weeks
Measured: 12 weeks
Oswestry Disability Index (ODI) for disability:
Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. The ODI can be used to assess both chronic and acute conditions of varying severity. It has high test-retest reliability and takes around 5min for a patient to complete. assessment to be done at base line after 6 weeks and after detraining of 6 weeks.
Measured: 6 weeks
Oswestry Disability Index (ODI) for disability:
Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. The ODI can be used to assess both chronic and acute conditions of varying severity. It has high test-retest reliability and takes around 5min for a patient to complete. assessment to be done at base line after 12 weeks and after detraining of 12 weeks.
Measured: 12 weeks
SHORT FORM-36 for HRQOL
The Short form -36 covers eight different dimensions of HRQOL: physical functioning, social functioning, role limitations due to physical functioning (role functioning-physical), bodily gain, general mental health, role limitations due to emotional functioning (role functioning-emotional), vitality (energy and fatigue), and general health perception. Scores can be summed together from all domains with differing weightings to contribute to two summary scores, a physical component score and a mental component score. The study findings indicate that the SF-36 is a reliable and valid instrument for assessment of HRQoL in patients. assessment to be done at base line after 6 weeks and after detraining of 6 weeks.
Measured: 6 weeks
SF-36 for HRQOL
The SF-36 covers eight different dimensions of HRQOL: physical functioning, social functioning, role limitations due to physical functioning (role functioning-physical), bodily gain, general mental health, role limitations due to emotional functioning (role functioning-emotional), vitality (energy and fatigue), and general health perception. Scores can be summed together from all domains with differing weightings to contribute to two summary scores, a physical component score and a mental component score. The study findings indicate that the SF-36 is a reliable and valid instrument for assessment of HRQoL in patients. assessment to be done at base line after 12 weeks and after detraining of 12 weeks.
Measured: 12 weeks
Secondary outcomes (12)
Physical fitness with flamingo test
The Flamingo Balance Test is total body balance test, and forms part of the Eurofit Testing Battery. This single leg balance test assesses the strength of the leg, pelvic, and trunk muscle as well as dynamic balance. purpose: To assess the ability to balance successfully on a single leg. assessment to be done at base line after 6 weeks and after detraining of 6 weeks.
Measured: 6 weeks
Physical fitness with flamingo test
The Flamingo Balance Test is total body balance test, and forms part of the Testing Battery. This single leg balance test assesses the strength of the leg, pelvic, and trunk muscle as well as dynamic balance. purpose: To assess the ability to balance successfully on a single leg. assessment to be done at base line after 12 weeks and after detraining of 12 weeks
Measured: 12 weeks
physical fitness with back endurance test:
The starting position is the patient/client adopting a half prone lying on a plinth with the superior edge of the iliac crest at the edge of the plinth and the arms crossed over the chest. The lower limbs are strategically stabilized with straps. The patient/client is asked to maintains the upper body in a horizontal position and the timer is started. The test ends if the patient/client can maintain the said position for 4 minutes or can no longer maintain the set position before 4 minutes elapses. The stop time is recorded. Assesment to be done at baseline after 6 weeks and detraining of 6 weeks.
Measured: 6 weeks
physical fitness with back endurance test:
The starting position is the patient/client adopting a half prone lying on a plinth with the superior edge of the iliac crest at the edge of the plinth and the arms crossed over the chest. The lower limbs are strategically stabilized with straps. The patient/client is asked to maintains the upper body in a horizontal position and the timer is started. The test ends if the patient/client can maintain the said position for 4 minutes or can no longer maintain the set position before 4 minutes elapses. The stop time is recorded. Assessment to be done at baseline after 12 weeks and detraining of 12 weeks.
Measured: 12 weeks
physical function with side bridge test
The trunk lateral endurance test, also called the side-bridge test, assesses muscular endurance of the lateral core muscles (i.e., transverse abdominis, obliques, quadratus lumborum, and erector spinae). This timed test involves static, isometric contractions of the lateral muscles on each side of the trunk that stabilize the spine. Assessment to be done at baseline after 6 weeks and detraining after 6 weeks.
Measured: 6 weeks
physical function with side bridge test
The trunk lateral endurance test, also called the side-bridge test, assesses muscular endurance of the lateral core muscles (i.e., transverse abdominis, obliques, quadratus lumborum, and erector spinae). This timed test involves static, isometric contractions of the lateral muscles on each side of the trunk that stabilize the spine. Assessment to be done at baseline after 12 weeks and detraining after 12weeks.
Measured: 12 weeks
physical function with abdominal curl-up test
The curl up test measures abdominal muscular strength and endurance of the abdominals and hip-flexors, important in back support and core stability. assessment to be done at baseline after 6 weeks and detraining after 6 weeks.
Measured: 6 weeks
physical function with abdominal curl-up test
The curl up test measures abdominal muscular strength and endurance of the abdominals and hip-flexors, important in back support and core stability. assessment to be done at baseline after 12 weeks and detraining after 12 weeks.
Measured: after 12 weeks
physical function with 60-s squat test:
To test lower body muscle endurance. Perform for the greatest possible number of repetitions in 1 min without carrying out assisted movements using other body segments assessment to be done at baseline after 6 weeks and detraining after 6 weeks.
Measured: 6 weeks
physical function with 60-s squat test:
To test lower body muscle endurance. Perform for the greatest possible number of repetitions in 1 min without carrying out assisted movements using other body segments assessment to be done at baseline after 12 weeks and detraining after 12 weeks.
Measured: 12 weeks
Biofeedback pressure unit
The unit consists of a combined gauge and inflation bulb connected to a pressure cell. Designed by physical therapists, the Stabilizer registers changing pressure in an air-filled pressure cell allowing body movements to be detected during exercise. The Pressure Biofeedback Unit is a reliable tool when utilized with a population of subjects that can perform the abdominal drawing-in test. assessment to be done at baseline after 6 weeks and detraining after 6 weeks
Measured: 6 weeks
Biofeedback pressure unit
The unit consists of a combined gauge and inflation bulb connected to a pressure cell. Designed by physical therapists, the Stabilizer registers changing pressure in an air-filled pressure cell allowing body movements to be detected during exercise. The Pressure Biofeedback Unit is a reliable tool when utilized with a population of subjects that can perform the abdominal drawing-in test. Assessment to be done at baseline after 12 weeks and detraining after 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start30 Apr 2022
- Primary completion1 Aug 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Khalid, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449262
- Sponsor's protocol ID
- REC 01054 Hafiza Sana Asad
- Status last verified
- Sep 2022
- First submitted
- 4 Jul 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Course Effects of Functional Resistance Training on Fitness and Quality of Life in Patients With Nonspecific Chronic Low-back Pain
- ClinicalTrials.gov ID
- NCT05449262
- Acronym / sponsor ID
- REC 01054 Hafiza Sana Asad
- Conditions
- Chronic Low-back Pain
- Keywords
- Pain, disability, strength, quality of life, functional resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low back pain is categorized according to its duration as acute (<6 weeks), sub-acute (6 weeks - 12 weeks) and chronic (>12 weeks). Low back pain can be either specific or non-specific. Specific low back pain is because of specific spinal pathologies including; Malignancy, Infection, Osteoporotic Collapse, Fracture, Ankylosing Spondylitis or other inflammatory disorders and Cauda equina compression. About 19 in 20 cases of acute (sudden onset) low back pain are classed as 'non-specific' It is called 'non-specific' because it is usually not clear what is actually causing the pain or there is no specific problem or disease that can be identified as to the cause of the pain.Functional Resistance Training (FRT) involves multiplanar and multi joint resistance exercises that simulate movement patterns from everyday life and sport Functional training exercises tend to focus more on the coordination, technique, posture, and core engagement instead of on training loads.
Detailed description
The lower back is also called the 'lumbosacral area' of the back. It is the part of the back between the bottom of the ribs and the top of the legs and is made up of the spine bones (vertebrae), discs, nerves, muscles and ligaments. Pain in this region is called low back pain. (1) Low back pain is categorized according to its duration as acute (<6 weeks), sub-acute (6 weeks - 12 weeks) and chronic (>12 weeks). About 19 in 20 cases of acute (sudden onset) low back pain are classed as 'non-specific' It is called 'non-specific' because it is usually not clear what is actually causing the pain or there is no specific problem or disease that can be identified as to the cause of the pain. It is said that cause may be a sprain (an over-stretch) of a ligament or muscle, minor problem with the disc between two vertebrae, or a minor problem with a small 'facet' joint between two vertebrae. It is not possible to identify these causes of the pain by tests. Therefore, it is usually impossible to say exactly where the pain is coming from, or exactly what is causing the pain. Sometimes a pain may develop immediately after lifting something heavy, or after an awkward twisting movement. Sometimes it can develop for no apparent reason. Some people just wake up one day with low back pain. Typically the pain is in one area of the lower back, but sometimes it spreads to one or both buttocks or thighs. Non-specific low back pain is 'mechanical' in the sense that it varies with posture or activity. In a small number of cases the pain persists for several months or longer. This is called chronic back pain. There is no test that can prove or confirm non-specific low back pain.
Non-specific low back pain is classed as chronic (persistent) if it lasts longer than six weeks. In some people it lasts for months, or even years. Symptoms may be constant. Non-specific low back pain affects people of all ages and is a leading contributor to disease burden worldwide.
The ACSM defines functional RT (FRT) as activities involving multiple muscle, joint, and planar activities that are closely related to activities of daily living, combining upper and lower body movements to use more of the body in each movement. Few studies have examined FRT, though initial results suggest that FRT is associated with higher caloric expenditure and similar muscular strength, endurance, and gains in flexibility compared with a TRT program.
Functional training is becoming increasingly popular within the fitness industry and has been considered to be a better alternative than traditional resistance training for improving various measures of muscular fitness including strength, endurance, coordination and balance. The verb form of the word "function" pertains to the performance of an action, work or activity. Thus, exercise training programs that are deemed to be "functional" should be designed to mimic tasks or activities that occur in a person's daily life to make training adaptations more transferable. Engaging in regular RT provides physical, physiological and psychological health benefits while providing additional bone health benefits. Although RT has greatly increased in popularity, other types of training aside from traditional RT (TRT) have yet to be examined. One such type of training, ''functional fitness,'' is defined by the ACSM as the use of strength training to improve balance and ease of living, and was in the top 10 fitness trends in 2018.
Functional Resistance Training (FRT) involves multiplanar and multi joint resistance exercises that simulate movement patterns from everyday life and sport Functional training exercises tend to focus more on the coordination, technique, posture, and core engagement instead of on training loads. The goal of FRT is not hypertrophy but to promote a potential motor problem in order to train dynamic stabilization. Appropriate functional exercises are those in which the lumbo-pelvic region remains aligned within the neutral zone by co-contraction of the muscles of the trunk, while other demands executed with the extremities are simultaneously and successfully fulfilled. This method of training usually includes: a) spinal stabilization exercises; b) balance and proprioceptive exercises; c) flexibility exercises; d) resistance training exercises.
Functional RT may be more feasible and accessible due to the minimal equipment needed and the flexibility to be performed in and out of a typical gym setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| functional resistance training GROUP A | Experimental | Other: functional resistance training GROUP ASession of 45-60 min starting with Warm Up Exercise and stretching prior to therapy and cool-down and stretching after the training sessions |
| functional resistance training GROUP B | Experimental | Other: functional resistance training GROUP BSession of 45-60 min starting with Warm Up Exercise and stretching prior to therapy and cool-down and stretching after the training sessions |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient having low back pain as a primary complaint, without associated leg pain;
- Chronic pain (>= 3 months, >= 3 days/week)
- non- specific (soft tissue in origin)
- Patient having no history of formal exercise training.
- Learning proper technique under expert supervision
Key exclusion criteria (8 listed)
- Receiving concurrent treatments from another practitioner for LBP
- Congenital deformities of spine
- Neurological conditions (neuropathy, radiculopathy)
- Musculoskeletal conditions (fractures, atrophy, weakness)
- Cardiovascular, Nephrological conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional resistance training GROUP ASession of 45-60 min. Warm up prior to training Warm up 6-7 min of mild cardiovascular exercise followed by 3-4 min stretching Cool down post training A cool-down of 1 min of mild cardiovascular exercise followed by 4 min of stretching | Other | functional resistance training GROUP A |
| functional resistance training GROUP BSession of 45-60 min Warm up prior to training Warm up 6-7 min of mild cardiovascular exercise followed by 3-4 min stretching Cool down post training A cool-down of 1 min of mild cardiovascular exercise followed by 4 min of stretching | Other | functional resistance training GROUP B |
Primary outcome
Visual analogue scale (VAS)for pain:
Time frame: 6 weeks
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. it is scientifically evident that VAS is a reliable and valid scale in aged more than 18 years. In many studies it is proved that VAS is a reliable scale but for validity it showed moderate to strong correlation for pain measurement. assessment to be done at base line after 6 weeks and after detraining of 6 weeks
Visual analogue scale (VAS)for pain:
Time frame: 12 weeks
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. it is scientifically evident that VAS is a reliable and valid scale in aged more than 18 years. In many studies it is proved that VAS is a reliable scale but for validity it showed moderate to strong correlation for pain measurement. assessment to be done at base line after 12 weeks and after detraining of 12 weeks
Oswestry Disability Index (ODI) for disability:
Time frame: 6 weeks
Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. The ODI can be used to assess both chronic and acute conditions of varying severity. It has high test-retest reliability and takes around 5min for a patient to complete. assessment to be done at base line after 6 weeks and after detraining of 6 weeks.
Oswestry Disability Index (ODI) for disability:
Time frame: 12 weeks
Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. The ODI can be used to assess both chronic and acute conditions of varying severity. It has high test-retest reliability and takes around 5min for a patient to complete. assessment to be done at base line after 12 weeks and after detraining of 12 weeks.
SHORT FORM-36 for HRQOL
Time frame: 6 weeks
The Short form -36 covers eight different dimensions of HRQOL: physical functioning, social functioning, role limitations due to physical functioning (role functioning-physical), bodily gain, general mental health, role limitations due to emotional functioning (role functioning-emotional), vitality (energy and fatigue), and general health perception. Scores can be summed together from all domains with differing weightings to contribute to two summary scores, a physical component score and a mental component score. The study findings indicate that the SF-36 is a reliable and valid instrument for assessment of HRQoL in patients. assessment to be done at base line after 6 weeks and after detraining of 6 weeks.
SF-36 for HRQOL
Time frame: 12 weeks
The SF-36 covers eight different dimensions of HRQOL: physical functioning, social functioning, role limitations due to physical functioning (role functioning-physical), bodily gain, general mental health, role limitations due to emotional functioning (role functioning-emotional), vitality (energy and fatigue), and general health perception. Scores can be summed together from all domains with differing weightings to contribute to two summary scores, a physical component score and a mental component score. The study findings indicate that the SF-36 is a reliable and valid instrument for assessment of HRQoL in patients. assessment to be done at base line after 12 weeks and after detraining of 12 weeks.
12 secondary outcomes
Physical fitness with flamingo test
Time frame: 6 weeks
Physical fitness with flamingo test
Time frame: 12 weeks
physical fitness with back endurance test:
Time frame: 6 weeks
physical fitness with back endurance test:
Time frame: 12 weeks
physical function with side bridge test
Time frame: 6 weeks
physical function with side bridge test
Time frame: 12 weeks
physical function with abdominal curl-up test
Time frame: 6 weeks
physical function with abdominal curl-up test
Time frame: after 12 weeks
physical function with 60-s squat test:
Time frame: 6 weeks
physical function with 60-s squat test:
Time frame: 12 weeks
Biofeedback pressure unit
Time frame: 6 weeks
Biofeedback pressure unit
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Khalid, MSOMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing functional resistance training GROUP A and functional resistance training GROUP B in people with Chronic Low-back Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS)for pain: (time frame: 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.