Pain ThresholdNCT04482075
Relationship Between Pressure Pain Threshold and Pain Intensity, Affect and Disability in CLBP
A study testing segmental stability training in people with Pain Threshold and Low Back Pain, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
The association between pressure pain threshold and different aspects of low back pain has garnered attention over the years. However, since most of such studies in the past employed cross sectional designs, a longitudinal study design with follow-up measurements is required to further investigate this relationship. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Pain Threshold, Low Back Pain, Pain Measurement
- What is being tested?
- segmental stability training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2019to 16 Jan 2021
- 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 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Adult males with low back pain with an age group of 18-50 years.
Who cannot join
- Individuals having low back pain for less than 3 months.
- Individuals with specific underlying pathology as the cause of CLBP. (Active oncological disease, Known disc derangement, cauda equina syndrome, spinal trauma i.e. fracture, neuropathy i.e. sciatica or severe root compression, spinal structural deformity, infection, inflammatory joint disease, spinal stenosis, spondylolysis, spondylolisthesis).
- Individuals having neurological diseases (including central and peripheral diseases); metabolic diseases (i.e. diabetes and hypothyroidism); coagulopathies (i.e. haemophilia).
- Individuals with fibromyalgia syndrome (FMS); myofascial pain syndrome (MPS); allodynia (stroking hyperalgesia).
- Individuals suffering from aphasia or suffering from deafness, blindness or muteness.
- Individuals with skin disease (i.e. psoriasis, scleroderma, leprosy, etc.) or skin lesions (i.e. abrasion/laceration/ bruise) in the low back region.
Show all 12Show fewer
- Individuals having oral temperature of 100 F or above.
- Individuals who have undergone spinal surgery.
- Individuals scoring 28+ for depression, 20+ for anxiety, 34+ for stress on DASS-21.
- Individuals in whom prone lying causes significant discomfort (i.e. dyspnoea etc.).
- Individuals who do not perceive pressure pain below 10 kg/cm2 during PPT testing.
- Individuals evincing bruising to PPT testing.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Institute of Physical medicine & Rehabilitation, Dow University of Health Sciences
Karachi, Sindh
About this study
Official title: Cross-modality Matching Between Pressure Pain Threshold and Subjective Ratings of Pain Intensity, Affect and Disability in Patients With Chronic Low Back Pain.
The association between pressure pain threshold and different aspects of low back pain has garnered attention over the years. However, since most of such studies in the past employed cross sectional designs, a longitudinal study design with follow-up measurements is required to further investigate this relationship. Studying this relationship will not only offer insights into the phenomenon of pain but may also bring us one step closer to achieving the seemingly insurmountable goal of objectively measuring back pain and its different dimensions.
Read the detailed description
This study is aimed to examine and evaluate the true extent of the relationship between pressure pain threshold (PPT) and different aspects of somatic pain, by studying the interplay between PPT and different variables, and by further exploring the predictive capability of PPT values to estimate pain intensity, pain affect and disability associated with chronic low back pain (CLBP). In order to estimate these dimensions a calculator based on mathematical equations using different predictive models will be developed. This tool (calculator) will take into account PPT reading from the lower back region and some other variables having confounding effects on PPT and pain, and will be able to predict pain intensity, affect and associated disability with reasonable accuracy. Patients with chronic low back pain shall be the target population and shall be recruited through referrals from the medical Out-Patients Department of Institute of Physical Medicine \& Rehabilitation, Dow University of Health Sciences and Department of Rehabilitation Medicine PNS-Shifa Hospital, Karachi, Pakistan after initial screening in accordance with the inclusion and exclusion criteria. Screened patients shall then be briefed about the research project. After explaining the study objectives, procedures, potential benefits and discomforts, written informed consent shall be obtained from the patients. Only upon their agreement shall they become study participants and undergo assessments. The study participants shall receive handouts to document Depression and Anxiety, Pain Intensity, Pain Affect, and Disability. Pressure pain threshold (PPT) shall be measured using a manual Algometer. These measurements shall be followed by a session of physiotherapy treatment, after which Pain Intensity, Pain Affect, and Disability shall be recorded again.
- Conditions
- Pain Threshold, Low Back Pain, Pain Measurement
- Being tested
- segmental stability training
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
segmental stability trainingOther
SEGMENTAL STABILISATION TRAINING (SST): This part of the therapy shall involve Isometric co-contraction of Lumbar Transversus abdominis and Lumbar Multifidus. The patient shall perform 10 repetitions of abdominal drawing-in manoeuvre with 30-40% Maximal Voluntary Contraction (MVC) with a 10-second hold in specific prescribed positions.
| Study group | Role | What they receive |
|---|---|---|
| SEGMENTAL STABILISATION TRAINING (SST) | Other | Segmental Stabilisation Training is an established treatment technique for chronic low back pain Receives: Other: segmental stability training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure threshold meter
Its a type of force gauge which consists of a rubber-tipped plunger with a surface area of usually 1cm square, connected to the force gauge (body) via a metal rod. The force gauge is usually calibrated in Newtons or Kilograms per cm2 with a range of up to 10 kgs. The exerted pressure on the plunger is transmitted to the gauge through the metal rod, which in turn moves the indicator needle in the clockwise direction with a magnitude corresponding to the force applied. The indicator needle remains in this position until the zeroing knob is pressed, which brings the needle back to its starting position. This allows the examiner to record the last reading of the pressure applied after removing the device from the body.
Measured: Up to 2 weeks
Visual Analogue scale (VAS) - pain intensity
Visual Analogue scale furnished with specific anchors to measure pain intensity. It is a continuous scale that is considered as a unidimensional measure of the pain experience. It consists of a 100 mm straight line, anchored by descriptors such as 'no pain at all' (0mm) and 'worst pain imaginable' (100mm) at both extremes. The respondent marks the line which corresponds to the current state of pain. Scoring is done with the help of a ruler and the whole process takes about a minute to complete. VAS demonstrates ratio-scale properties and it can be adapted to assess dimensions other than intensity such as unpleasantness (affective dimension) associated with pain.
Measured: Up to 2 weeks
Visual Analogue scale (VAS) - pain affect
Visual analogue scale fine-tuned to measure pain affect with specific anchors. In general, the same technique used for assessing the pain intensity may be used to assess the pain affect. It consists of a 100 mm straight line, anchored by descriptors such as ''not bad at all'' (0mm) and ''the most unpleasant feeling possible for me'' (100mm) at both extremes. The respondent marks the line which corresponds to the current state of pain. Scoring is done with the help of a ruler and the whole process takes about a minute to complete.
Measured: Up to 2 weeks
Disability Rating Index (DRI)
This article focuses on the Disability Rating Index (DRI), a patient-reported outcome measure developed by Salén et al. in 1994, with the aim of measuring the physical disability of respondents within a clinical setting. The DRI evaluates a respondent's disability by assessing activity and participation limitations. It covers 12 non-specific activities of daily life, each one self-rated on a visual analogue scale of 0-100 mm, providing a score of 0-100 for each activity, where 0 represents no difficulty in performing the specific task and 100 indicates an inability to perform the task at all.
Measured: Up to 2 weeks
Secondary outcomes (2)
Saltin-Grimby Physical Activity Level Scale (SGPALS)
It's a four-level questionnaire to assess leisure-time physical activity (PA). It is anchored by descriptors such as "physically inactive" (0) and "regular hard physical training for competitive sports" (4).
Measured: At baseline
Depression, Anxiety and Stress Scale (DASS-21)
This is a set of three self-report scales designed to measure the emotional states of depression, anxiety \& stress. The minimum score lies between 0 - 3 (normal) and the maximum score 14 and above (Extremely Severe). For Anxiety 0 - 3 (normal) and the maximum score 10 and above (Extremely Severe) and For Stress 0 - 7 (normal) and the maximum score 17 and above (Extremely Severe).
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start1 Jul 2019
- Primary completion23 Dec 2020
- Study completion16 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ThresholdStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rasim Ul Hasanat Qureshi, MSPT, Principal investigator, Dow University of Health SciencesShahzad Ali Syed, MSAPT, Study director, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482075
- Sponsor's protocol ID
- 00002
- Status last verified
- Aug 2021
- First submitted
- 22 Feb 2020
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ul Hasanat R, Syed SA, Rathore FA, Iftikhar S. Development of a tool for objectively measuring somatic pain in the low back region based on a longitudinal diagnostic study conducted in Karachi, Pakistan. BMJ Open. 2023 Mar 16;13(3):e067129. doi: 10.1136/bmjopen-2022-067129.
PubMed 36927595
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-modality Matching Between Pressure Pain Threshold and Subjective Ratings of Pain Intensity, Affect and Disability in Patients With Chronic Low Back Pain.
- ClinicalTrials.gov ID
- NCT04482075
- Acronym / sponsor ID
- 00002
- Conditions
- Pain Threshold, Low Back Pain, Pain Measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 23 Dec 2020 (actual)
- Study completion
- 16 Jan 2021 (actual)
- First posted
- 22 Jul 2020 (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.
The association between pressure pain threshold and different aspects of low back pain has garnered attention over the years. However, since most of such studies in the past employed cross sectional designs, a longitudinal study design with follow-up measurements is required to further investigate this relationship. Studying this relationship will not only offer insights into the phenomenon of pain but may also bring us one step closer to achieving the seemingly insurmountable goal of objectively measuring back pain and its different dimensions.
Detailed description
This study is aimed to examine and evaluate the true extent of the relationship between pressure pain threshold (PPT) and different aspects of somatic pain, by studying the interplay between PPT and different variables, and by further exploring the predictive capability of PPT values to estimate pain intensity, pain affect and disability associated with chronic low back pain (CLBP). In order to estimate these dimensions a calculator based on mathematical equations using different predictive models will be developed. This tool (calculator) will take into account PPT reading from the lower back region and some other variables having confounding effects on PPT and pain, and will be able to predict pain intensity, affect and associated disability with reasonable accuracy. Patients with chronic low back pain shall be the target population and shall be recruited through referrals from the medical Out-Patients Department of Institute of Physical Medicine \& Rehabilitation, Dow University of Health Sciences and Department of Rehabilitation Medicine PNS-Shifa Hospital, Karachi, Pakistan after initial screening in accordance with the inclusion and exclusion criteria. Screened patients shall then be briefed about the research project. After explaining the study objectives, procedures, potential benefits and discomforts, written informed consent shall be obtained from the patients. Only upon their agreement shall they become study participants and undergo assessments. The study participants shall receive handouts to document Depression and Anxiety, Pain Intensity, Pain Affect, and Disability. Pressure pain threshold (PPT) shall be measured using a manual Algometer. These measurements shall be followed by a session of physiotherapy treatment, after which Pain Intensity, Pain Affect, and Disability shall be recorded again.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SEGMENTAL STABILISATION TRAINING (SST) | Other | Other: segmental stability trainingSegmental Stabilisation Training is an established treatment technique for chronic low back pain |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult males with low back pain with an age group of 18-50 years.
Key exclusion criteria (12 listed)
- Individuals having low back pain for less than 3 months.
- Individuals with specific underlying pathology as the cause of CLBP. (Active oncological disease, Known disc derangement, cauda equina syndrome, spinal trauma i.e. fracture, neuropathy i.e. sciatica or severe root compression, spinal structural deformity, infection, inflammatory joint disease, spinal stenosis, spondylolysis, spondylolisthesis).
- Individuals having neurological diseases (including central and peripheral diseases); metabolic diseases (i.e. diabetes and hypothyroidism); coagulopathies (i.e. haemophilia).
- Individuals with fibromyalgia syndrome (FMS); myofascial pain syndrome (MPS); allodynia (stroking hyperalgesia).
- Individuals suffering from aphasia or suffering from deafness, blindness or muteness.
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 |
|---|---|---|
| segmental stability trainingSEGMENTAL STABILISATION TRAINING (SST): This part of the therapy shall involve Isometric co-contraction of Lumbar Transversus abdominis and Lumbar Multifidus. The patient shall perform 10 repetitions of abdominal drawing-in manoeuvre with 30-40% Maximal Voluntary Contraction (MVC) with a 10-second hold in specific prescribed positions. | Other | SEGMENTAL STABILISATION TRAINING (SST) |
Primary outcome
Pressure threshold meter
Time frame: Up to 2 weeks
Its a type of force gauge which consists of a rubber-tipped plunger with a surface area of usually 1cm square, connected to the force gauge (body) via a metal rod. The force gauge is usually calibrated in Newtons or Kilograms per cm2 with a range of up to 10 kgs. The exerted pressure on the plunger is transmitted to the gauge through the metal rod, which in turn moves the indicator needle in the clockwise direction with a magnitude corresponding to the force applied. The indicator needle remains in this position until the zeroing knob is pressed, which brings the needle back to its starting position. This allows the examiner to record the last reading of the pressure applied after removing the device from the body.
Visual Analogue scale (VAS) - pain intensity
Time frame: Up to 2 weeks
Visual Analogue scale furnished with specific anchors to measure pain intensity. It is a continuous scale that is considered as a unidimensional measure of the pain experience. It consists of a 100 mm straight line, anchored by descriptors such as 'no pain at all' (0mm) and 'worst pain imaginable' (100mm) at both extremes. The respondent marks the line which corresponds to the current state of pain. Scoring is done with the help of a ruler and the whole process takes about a minute to complete. VAS demonstrates ratio-scale properties and it can be adapted to assess dimensions other than intensity such as unpleasantness (affective dimension) associated with pain.
Visual Analogue scale (VAS) - pain affect
Time frame: Up to 2 weeks
Visual analogue scale fine-tuned to measure pain affect with specific anchors. In general, the same technique used for assessing the pain intensity may be used to assess the pain affect. It consists of a 100 mm straight line, anchored by descriptors such as ''not bad at all'' (0mm) and ''the most unpleasant feeling possible for me'' (100mm) at both extremes. The respondent marks the line which corresponds to the current state of pain. Scoring is done with the help of a ruler and the whole process takes about a minute to complete.
Disability Rating Index (DRI)
Time frame: Up to 2 weeks
This article focuses on the Disability Rating Index (DRI), a patient-reported outcome measure developed by Salén et al. in 1994, with the aim of measuring the physical disability of respondents within a clinical setting. The DRI evaluates a respondent's disability by assessing activity and participation limitations. It covers 12 non-specific activities of daily life, each one self-rated on a visual analogue scale of 0-100 mm, providing a score of 0-100 for each activity, where 0 represents no difficulty in performing the specific task and 100 indicates an inability to perform the task at all.
2 secondary outcomes
Saltin-Grimby Physical Activity Level Scale (SGPALS)
Time frame: At baseline
Depression, Anxiety and Stress Scale (DASS-21)
Time frame: Up to 2 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 18 Aug 2021.
- Derived from this study: PubMed 36927595Ul Hasanat R, Syed SA, Rathore FA, Iftikhar S. Development of a tool for objectively measuring somatic pain in the low back region based on a longitudinal diagnostic study conducted in Karachi, Pakistan. BMJ Open. 2023 Mar 16;13(3):e067129. doi: 10.1136/bmjopen-2022-067129.
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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.
Rasim Ul Hasanat Qureshi, MSPT principal investigator
Dow University of Health Sciences
Shahzad Ali Syed, MSAPT study director
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing segmental stability training in people with Pain Threshold and Low Back Pain, run by Dow University of Health Sciences 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 1 inclusion and 12 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 18 Aug 2021. 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?
Pressure threshold meter (time frame: Up to 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04482075, which also lists 1 linked publication.
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 18 Aug 2021.