Prologel Research

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Prologel-Study for Topical and Ultrasound Pain Relief-Howard Rosen, M.D.

Abstract

Prologel is a proprietary blend of ingredients to promote pain relief, which can be applied with or without ultrasound. Seventeen patients were treated with several painful conditions.  A VAS was used before and after treatment.  The results yielded an over 93% pain reduction in the Prologel group treated with ultrasound, and an 81% pain reduction in the non-ultrasound treated group. The pain reduction over time was not studied, but anectdotally appeared to decrease over time.

Conclusion: Prologel was an effective pain reduction treatment.

Prologel is a new pain relief cream largely developed as an adjunct for pain relief for use in a chiropractor’s practice. Prologel is a proprietary blend of ingredients. Prologel has been used in chiropractic practices in two separate ways. First, the chiropractor applies the Prologel by ultrasound. Secondly, the chiropractor resells the Prologel to the patient. Therefore, it was important to study Prologel for both simple topical as well as ultrasound use.

Methods

In this prospective study, 17 patients were treated with ProloGel for various forms of pain. The pain locations were as follows: neck, plantar fascitis, carpal tunnel, abdominal wall pain of undetermined etiology, ankle, extensor arm, supraspinatus (shoulder pain), Achilles tendon, generalized shoulder pain after an injection, knee, wrist, low back, rheumatoid Arthritis and complex regional pain (CRPS formally known as RSD). The first group of 7 patients with a combined total of 8 body parts were treated with ultrasound and ProloGel The pain scores averaged 7.1 pre-treatment, and fell to a .5 post-treatment, which is a 93% drop in pain scores. Six of the ten treatments resulted in no reported pain. The second group contained 11 patients with a combined total of 12 body parts, and were treated topically with ProloGel. The pain scores went from 6.3 pre-treatment, and fell to 1.2 post-treatment, which is an 81% drop in pain scores.

The patients’ pain scores were recorded. Some patients had multiple complaints of pain. Each body area was recorded separately. A Visual Analog Scale from 0-10 was utilized to determine pain scores. A ten indicated the worst pain the patient had ever experienced. A score of 0 indicated no pain at all. The patients were treated topically with Prologel for one minute. Depending on the patient’s request, the Prologel was applied topically either by rubbing or with the use of an ultrasound machine. The method of rubbing the Prologel on the patient topically lasted anywhere from 30 seconds to one minute. The utilization of the Prologel with the ultrasound was applied to the patient for 5 minutes. The patient was evaluated after one minute of treatment.

The results of the ultrasound and Prologel Max are:

Patient Complaint
VAS pre-treatment VAS post-treatment
1 Neck Pain 6 1
2 Plantar fascitis  6  0
Carpal Tunnel pain  6  0
3 Plantar fascitis pain  6  2
4 Bilateral Ankle Pain 4 0
5 Carparl Tunnel Pain 4 0
Extensor Ligament Pain 4 0
6 Achilles Tendon Pain 8 1
7 Knee Pain 6 0
Average 7.14 .5

The results of Topical Application of Prologel Max are:

Patient Complaint
VAS pre-treatment VAS post-treatment
1 Abdominal Pain 6 1
2 Knee Pain  6  1
 3 Knuckle Pain  6  0.5
4 Carpal Tunnel Pain  6  0
5 Supraspinatus pain 10 2
6 Wrist-Rheumatoid Arthritis 3 3
 7 Lower Back Pain 9 3
8 Foot-CRPS 3.4 1.5
9 Knee pain-Ankylosing Spondylitis 5 0
Achilles Tendon Pain 6 1
10 Wrist Pain 9 0
7 Low Back Pain 7 1.5
Average



6.3 1.2

Conclusions: The study was intended to determine if ProloGel would or would not produce immediate pain relief.. The pain scores fell quickly and dramatically in almost every category. The lone exception was found in the patient with rheumatoid arthritis in the wrist where no pain relief was obtained from the treatment. Carpal tunnel pain was reduced to zero in each treatment. For a chiropractic practice Prologel could both be applied via ultrasound in the office and  applied topically at home by the patient.  Further double blinded studies with Prologel is recommended. At the time of this writing,  a double-blinded study using Prologel with ultrasound is waiting IRB approval.

The purpose of the pilot study was to research immediate pain reduction not the lasting effects of a Prologel treatment. Anecdotally, the ultrasound treatments lasted much longer than the simple topical treatment.  A single Prologel ultrasound treatment appears to last for 1-2 days.  A single topical Prologel treatment without ultrasound lasted a few hours.  Further studies will be needed
to determine how long Prologel lasts with and without ultrasound.

Wrist Ganglion Cyst Reduction with Topical Prolotherapy Solution and Ultrasound

Howard Rosen, M.D. and Sheri Rosen, medical student

Abstract

Ganglion cysts are fluid filled collections of synovial fluid. 65% of the ganglions are located on the upper surface of the wrist with approximately 25% are located on the volar surface of the wrist. Wrist ganglions are generally non-painful. However, ganglions can be become painful due to their location, size or nerve involvement. There have been several methods to remove or reduce the size of a wrist ganglion. One of the oldest methods is the smashing the ganglion with a large book such as a Bible. This is an old home remedy for ganglion cysts that is not recommended by today’s experts. This is an old home remedy for ganglion cysts that are not recommended by today’s experts get rid of ganglion cysts, and could, in fact, cause more injury and unnecessary pain. This has been reported to have an initially high rate of success. However, there has been a high rate of reoccurrence of the ganglion. Aspiration of the cyst also has also been reported. There is a very high rate of reoccurrence. Aspiration and the instillation of steroids have also been reported. Anecdotal statements of reducing a wrist ganglion are noted on the web. No case studies or articles could be located on a pubmed or internet search. Surgical excision sometimes is used for ganglion removal. Arthroscopic surgical excision has been reported to be less invasive.

Methods

  • A dextrose-based solution was employed. It was combined with polyethylene glycol and DMSO to increase absorption.
  • To further increase absorption phonophoresis is employed. Phonophoresis is the use of ultrasound to enhance the delivery of topically applied drugs. Phonophoresis has been used in an effort to enhance the absorption of topically applied agents through the therapeutic application of ultrasound. The authors have proposed the name Prolophoresis.
  • Prolophoresis is the application of a prolotherapy-containing compound by phonophoresis.
  • These are two case reports with dramatic reduction is the size of the wrist ganglion using phonophoresis and Prologel.

Case presentations:

Case 1

The first case is a 56 year-old male. He reported having the wrist ganglion for over 20 years. The wrist ganglion was non-painful and non-tender. On physical examination, it was a left wrist ganglion. It was soft to palpation. It produced no discomfort to palpation. It was located on the dorsal surface on the wrist. A dorsal peripheral vein appeared to be located on top of the cyst. The ultrasound unit was purchased on Amazon for under $60. Low pulsed setting was used. Low pulsed has been reported to produce deepest penetration of a topical medication. The head of the ultrasound unit was filled with a small amount of Prologel.

  • The wrist was treated for 12 minutes. At the end of 12 minutes, there were no visible findings of the wrist ganglion. Only a small amount of the ganglion could be palpated between the carpal bones.
  • A week later approximately 25% of the wrist ganglion cyst returned.
  • This time, the ganglion was treated first with standard ultrasound gel from Parker lab for 12 minutes. No change was noted with the size of the ganglion.
  • The wrist ganglion was then treated with the Prologel and the ultrasound for 6 minutes. There were once again, no visible findings of the wrist ganglion. Only a small amount of the ganglion could be palpated between the carpal bones.
  • One week later approximately, 10% of the wrist ganglion cyst returned.
  • This time, the ganglion was treated first with standard ultrasound gel from Parker lab for 12 minutes. No change was noted with the size of the ganglion.
  • The wrist ganglion was then treated with the Prologel and the ultrasound for 6 minutes. There were once again, no visible findings of the wrist ganglion. Only a small amount of the ganglion could be palpated between the carpal bones.


Over the ensuing 4 months, the ganglion appeared to disappear without treatment. Ultrasound was available at this time. No ganglion remnant could be found on a diagnostic ultrasound office examination. 8 months after Prolophoresis treatment. At the time of the writing, it is 8 months after the last treatment. No remnant of the ganglion can palpated or located with ultrasound.

Case 2

This is a 68 year-old female with a chief complaint of a painful wrist. She presented with a large painful volar surface ganglion. 60 hours later an emergency room physician had drained the ganglion. It had re-accumulated. Accordingly, to the patient the ganglion was the same size or possibly bigger than her original ganglion presentation.

  • The ganglion was “rock hard” and painful to palpation. She had the ganglion drained 1.5 days earlier by an emergency room doctor. She stated the ganglion was larger than ever and it was hard for her to use this wrist. Surgery was only option she was offered.
  • A 5 a five-minute attempt to reduce the ganglion with just prolophoresis was unsuccessful.
  • The ganglion was then drained. (See photo).
  • The drained ganglion was treated with an additional 15 minutes of prolophoresis.
  • The patient was instructed to return in 2 days if the ganglion reformed. She was instructed to return in 5 days if it did not reform. She returned in 5 days. The ganglion was flatter and smaller than even after the drainage. She no longer had pain.
  • She returned 4 months later and her ganglion was still markedly reduced. See photo.
  • It was still not painful. She stated the best treatment she received was the prolophoresis and the aspiration combination.

Discussion:

Numerous theories have been proposed to explain the etiology of ganglion cysts. Eller first proposed in 1746 that ganglion cysts were herniations of synovial tissue. Most investigators have concluded that ganglion cysts arise from modified synovial or mesenchymal cells at eh synovial or mesenchymal cells at the synovial-capsular interface in response to repetitive minor injury.1 Ferrel et al demonstrated that stimulation of articular nerves resulted in plasma extravasation into synovial fluid. 2 The extravasation was mediated by afferent C-fibers. The plasma extravasation was noted to mediated by afferents containing substance P. There was reversible abolition of extravasation when the substance P. antagonist was injected into the synovial cavity.

Dr. John Lyftogt has proposed that dextrose 5% in sterile water can block C-fibers in the subcutaneous space. Brill has shown that ultrasound will deposit mediations in the subcutaneous space. Prologel contains dextrose. It has been postulated by the authors when Prologel is applied by ultrasound this combination will block C-fibers in the subcutaneous space.

The authors have further suggested the C-fibers are the producing the swelling of the synovial fluid in ganglion cysts. Furthermore, the Blocking the C-fibers quickly reverses the process and the swelling decreases rapidly. This is the proposed mechanism of the anecdotal reports of prolotherapy dextrose injections decreasing the size of ganglion cysts.

These case histories have shown that a dextrose containing solution such as Prologel can reduce the size of ganglion cysts when ultrasound is employed.

Techniques such as aspiration and Bible striking which to do not block the C-fibers will have a high rate of failure. Surgery excision is successful at a high rate only when the entire synovial sac including the stalk is removed.

Summary:

There have been many techniques to reduce or eliminate the size of wrist ganglion cysts. The methods employed range from no treatment, striking the ganglion with a Bible, aspiration alone, aspiration and instillation with a medication such as a steroid or dextrose, and surgical excision. Dias et al have reported the following results of long-term outcome of excision, aspiration and no treatment of dorsal wrist ganglia prospectively in over 200 patients. Twenty-three of 55 (58%) untreated ganglia resolved spontaneously. The recurrence rate was 58% and 39% following aspiration and excision, respectively. Approximately 8% of patients had complications following surgery. In their study, they concluded neither excision nor aspiration provided significant long-term benefit over no treatment.

These two cases illustrate the use of a topical proprietary prolotherapy solution to greatly reduce wrist ganglions. One wrist ganglion was on the dorsum, non-tender, and soft. The other wrist ganglion was on the volar surface, was painful and hard. The first ganglion was able to be successfully treated with only a topical prolotherapy solution. The second larger ganglion was able to be successfully treated with aspiration followed by a topical prolotherapy phonophoresis treatment when aspiration alone has failed.

The term prolophoresis to be defined as application of a prolotherapy-containing compound by phonophoresis is proposed.

Months after treatment both ganglia were still greatly reduced. Prolophoresis is suggested as a possible treatment for ganglion cysts. For smaller ganglions prolophoresis alone can be used and prolophoresis with aspiration can be used for larger cysts.

References

The Natural History of Untreated Dorsal Wrist Ganglia and Patient Reported Outcome 6 Years after Intervention

1. J. J. DIAS

2. V. DHUKARAM

3. P. KUMAR

4. From the Glenfield Hospital, University Hospitals of Leicester, Leicester, UK

5. Mr J.J. Dias, Consultant Orthopaedic Surgeon, Glenfield Hospital, Leicester LE3 9QP, UK. Tel.: +44 116 2563089; fax: +44 116 2502676. E-mail: joseph.dias@uhl-tr.nhs.uk

Ankle Trauma Pain Relief & Healing